Policyholder Services

AMO/Abbott Recall Alert: Responding to the Recent Voluntary Recall Notice Regarding Incorrectly Labeled IOLs

OMIC policyholders have called to report receipt of a voluntary recall notice from Abbott Medical Optics (AMO), stating that some Silicone Tecnis IOLs may have been labeled with the incorrect diopter power. The letter states that “implanted IOLs with appropriate post-op refractive outcomes are not affected by this recall.” OMIC spoke with a representative at AMO/Abbott, who explained that it is the label itself which may be incorrect, and that this label is on the package, the patient card, and the sticker that is placed in the record. There are only a few patients who have reportedly been impacted by this possible mislabeling so far.

It is not clear if physicians have a legal duty to disclose the recall to every patient who may be impacted. OMIC feels, nonetheless, that it would be best to disclose to all patients. Accordingly, we would suggest insured ophthalmologists prepare two disclosure letters. We are happy to review the letters before policyholders send them out (email us at riskmanagement@omic.com).

We propose the following course of action:

The physician reviews review the medical records of all patients who had implants covered by the recall.

If the refractive outcome is deemed appropriate:

• The physician documents the review and the conclusion about the refractive outcome.
• The physician sends a letter explaining the recall and stating that he or she had reviewed the record and feels that the planned refractive outcome was achieved, and that no further action is needed.
• A copy of the letter is placed in the medical record.

If the refractive outcome does not seem appropriate:

• The physician documents the review and the conclusion that the refractive outcome may possibly be the result of a mislabeled IOL.
• The physician sends a letter explaining the recall and inviting the patient to come in for an examination and discussion of treatment options.
• The physician includes in the letter a contact number at Abbott for patients who would like to discuss the situation with Abbott (or even a copy of the recall letter).
• The practice reports the outcome to Abbott as requested in the recall notice, and documents that communication.

OMIC policyholders should call the Hotline with additional questions or concerns.

OMIC’s risk management advice is informational only and is not intended to be legal advice. If specific legal advice is desired, please contact your attorney.