MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SA60AT

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Based on the results from the product and batch history record, the product met release criteria.Root cause cannot be identified at this time.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported an intraocular lens (iol) was in a defective position and had a folding line on the optic part.Additional information was requested.

Manufacturer Narrative

Additional information provided in d.10., g.1., g.2., h.3., h.6., and h.10.The product was returned and the optic was observed to be scratched/marked, which may have been interpreted as the reported complaint "folding line on optic".The file has a few photos provided.Only pic2 belongs to the reported complaint (sn 21238877 039).Pic2 shows only a carton box.No iol or lens case photos are attached for the reported complaint.The file has 6 photos attached, some of which belongs to other complaints.Pic4 shows iol in a computer screen.It appears to be scratched/marked and it appears to have solution on it.No sn or information about which qs this photo belongs were provided.Iol returned posterior surface up instead of anterior surface up in the iol case.Solution is dried on both surfaces of the optic and haptics.The optic is scratched/marked-rejectable.We are unable to determine a root cause for the reported complaint.The returned iol shows evidence of possible handling due to the presence of solution and how it was returned positioned posterior surface up instead of anterior surface up in the iol case.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed optic damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• MDR Report Key: 9234030
• MDR Text Key: 177409596
• Report Number: 9612169-2019-00337
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.190
• Device Lot Number: 21238877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SA60AT.200FX; SA60AT.210FX; SA60AT.225FX; SN60WF.205