Light Adjustable Lens (LAL)

Description of Event or Problem

A site reported that a patient's Light Adjustable Lens (LAL) was explanted and replaced with a new LAL due to declining vision. Following the initial LAL implantation, the patient did not return to begin light treatments until approximately two years after implantation. One adjustment and both lock-ins were performed prior to lens explant. No further information was provided.

Additional Manufacturer Narrative

Manufacturing records were reviewed and found no deviations, non-conformances, or other manufacturing issues related to the reported event.A definitive cause for the reported declining vision could not be determined. As no light treatments were performed postoperatively until approximately 2 years after implantation, it may have been a contributing factor.Per the Instructions for Use (IFU), use of the LAL is contraindicated in cases where: "The patient is unwilling to comply with the postoperative regimen for adjustment and lock-in treatments and wearing of UV protective eyewear." Additionally, "Seventeen (17) to 21 days after surgery, the patient is to return for examination and a 1st adjustment treatment. Subsequent second and third adjustment treatments, if necessary, are all separated by 3-5 days. The subject will receive the 1st lock-in treatment 3-5 days after the final adjustment treatment. If necessary, Lock-in #2 may be performed 3-5 days after lock-in #1."Manufacturer Reference #: (b)(4).