MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number MN60MA

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis; the lens remains implanted.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant surgery, the surgeon noticed a defect on the lens.He did not remove the lens, and he will monitor the patient.In an email response, the physician reported, "yes there was some kind of sticky substance on the optic that i tried to peel off and brush off with the i/a tip.There was also a small clump attached to the haptic.No idea what it was it was almost the consistency of dried glue, or a sticker that has been peeled off." additional information has been requested.

Manufacturer Narrative

The product was not returned for evaluation.Iol product history records were reviewed and documentation indicated the product met release criteria.A qualified company ii (b) cartridge was indicated.It is unknown if a qualified handpiece and viscoelastic were used.The provided photos were reviewed by hwv and ftw r&d.The photos show a very white material on one haptic near the insertion area.Another area is observed, which appears to be under the lens.The material appears more liquid than a solid particulate.No determination can be made as to the nature of the material from this photo.The lens remains implanted.The product investigation could not identify a root cause.The product was not returned for evaluation.No determination can be made without physical evaluation of the complaint sample.The provided photos show a very white material on one haptic near the insertion area.Another area is observed, which appears to be under the lens.The material appears more liquid than a solid particulate.No determination of origin can be made from the photo.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10451281
• MDR Text Key: 205277051
• Report Number: 1119421-2020-01186
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MN60MA
• Device Catalogue Number: MN60MA.030
• Device Lot Number: 12729621
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1