Raindrop Near Vision Inlay Recalled

UPDATE: Device recalled 3/5/19

The FDA issued a Safety Alert about the Raindrop Near Vision Inlay on October 23, 2018. On March 5, 2019, the FDA recalled the device and updated the Safety Alert (https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm623973.htm), which states:

“People who undergo implantation of the Raindrop Near Vision Inlay device are at risk for the development of corneal haze that can affect clear vision. Haze can cause blurry vision or glare by clouding the cornea, or by changing the focusing power of the eye. The impact of haze on the patient’s vision is dependent on the severity of haze and its location in the cornea.”

The FDA made the following recommendations:

• Do not implant Raindrop inlays.
• Contact Optics Medical (Phone: 949-330-6511) for instructions on returning any unused product to the firm.
• Be aware of the new data from the ongoing post-approval study, which is showing 1) high rates of corneal haze in both implanted and explanted patients, 2) an increasing rate of device removal, and 3) that some cases of haze did not develop until 60 months post-implant.
• Monitor patients with the implant, and those whose device has been explanted, for the development of corneal haze.

Risk management recommendations (click “download” for the letter)

OMIC recommends that you take the following steps to promote patient safety and reduce your liability exposure:

PATIENTS ALREADY NOTIFIED OF THE SAFETY ALERT AND EVALUATED

• Update patients when they present for their next appointment.
• Share your current findings, and explain your plan for monitoring the eye.
• Educate them about symptoms that should be reported to you.
• Document the discussion.

PATIENTS WHO WERE NOT NOTIFIED OR NOT EVALUATED

• Send a Letter to patients about recall of Raindrop corneal inlay via regular mail, and ask them to call your office to make an appointment.
• Place a copy of the letter in the patient’s medical record, and send a copy to the referring ophthalmologist or optometrist.
• When you do examine the patient, determine if there are any signs of corneal haze or other problems.
• Share your findings with the patient, and explain your plan for monitoring the eye.
• Document the findings and discussion.

OMIC policyholders may obtain confidential advice by contacting our Risk Management Hotline at 800-562-6642, option 4, or riskmanagement@omic.com.

AMBest

Download OMIC’s current rating report at the link here.

The A.M.Best Company is the preeminent rating organization for our industry and is the oldest and most experienced rating agency in the United States. Best does an annual review of OMIC’s financial and operational performance and issues a rating based on this analysis. OMIC has maintained a favorable rating since first becoming eligible for a rating.

“The Best’s Rating Report(s) reproduced on this site appear under license from A.M. Best and do not constitute, either expressly or implied, an endorsement of (Licensee)’s products or services. A.M. Best is not responsible for transcription errors made in presenting Best’s Rating Reports. Best’s Rating Reports are copyright © A.M. Best Company and may not be reproduced or distributed without the express written permission of A.M. Best Company. Visitors to this website are authorized to print a single copy of the Best’s Rating Report(s) displayed here for their own personal use. Any other printing, copying or distribution is strictly prohibited.”

Financials

We encourage insureds to learn about how OMIC insurance represents an investment in your practice. To keep your premiums as low as possible, OMIC operates similar to a non-profit as we promise to return to insureds any premium above was is needed to prudently and conservatively run the company through dividend returns.

Learn more about our current financial performance here.

Learn more about our current history of dividends here.

To reduce premiums further, OMIC offers the most competitive risk management program discounts in the industry. OMIC offers ophthalmic-specific risk management programs throughout the year, including live seminars, audio conferences and CD recordings, and online courses. Learn more about available courses here.

OMIC has partnerships with most ophthalmic societies in the United States. Through this cooperative venture, our insureds who are members of partner societies earn additional discounts when participating in our risk management events. Learn more about the Cooperative Venture program here.

OMIC provides one of the most generous loss free discount programs in the industry and most our our insureds receive a credit.

Courses

There are many ways for insureds to participate in OMIC educational program.

OMIC offers ophthalmic-specific risk management programs throughout the year, including live seminars, audio conferences and CD recordings, and online courses. For live service now, contact the Risk Management Coordinator:

For Assistance: (800) 562-6642 (Press 652)    Message Us: lnakamura@omic.com

Live Courses

OMIC conducts live seminars for physicians and ancillary staff at locations throughout the country. View upcoming live events on OMIC’s calendar organized under the following categories audio conferences, physician seminars, staff courses, webinars, and events.

See the OMIC calendar.

Recordings

OMIC records certain events and audio conferences so that policyholders can listen to the seminar at their leisure.

See a list of OMIC CD Recordings.

Video and Webinar Courses

See a list of OMIC Online Courses.

Contact Linda Nakamura at lnakamura@omic.com  or 1-800-562-6642, ext. 652, to discuss other OMIC course options available to OMIC insureds.

Digest Vol 28 No 2 2018

Click image to download issue

Infection is a risk of all surgeries. Endophthalmitis is a particularly worrisome type of infection because it can lead to severe vision loss, blindness, and loss of the eye. Some types of complications are hard for patients to understand. They are familiar with infections, however, and realize that they can occur after surgery. This common knowledge makes it harder for plaintiffs in endophthalmitis claims to allege lack of informed consent.

In order to prove that their outcome was caused by malpractice and not the result of a known complication, plaintiffs must show that some aspect of the health care team’s treatment was below the standard of care.

OMIC published the results of its first analysis of endophthalmitis malpractice claims in 2006. At that
time, endophthalmitis claims made from 1987 to 2005 accounted for 6% of OMIC claims and 5% of indemnity payments. (read more…)