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

Model Number SA60AT

Device Problems Defective Component (2292); Material Deformation (2976)

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

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.(b)(4).

Event Description

A customer reported an intraocular lens (iol) was defective/deformed.Timing and patient impact are unknown.Additional information was requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The product was returned for analysis and the reported damage was observed.A photo shows iol sitting inside the lens case.The iol appears to be pressed against three (3) posts of lens case.The optic and one haptic appears to be bent/deformed.Additional observations were as follows: iol returned pressed against one (1) post of the lens case base resulting in deformation of the iol.Solution is dried on some areas the iol.One haptic is bent/deformed due to condition of returned sample.We are unable to determine the root cause for the reported complaint "bent in the lens case".The returned iol shows evidence of possible handling by the customer due to the presence of solution.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed haptic damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify that the damage was present when opened and 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: 9215400
• MDR Text Key: 168635083
• Report Number: 9612169-2019-00327
• 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,Followup
• Report Date: 02/12/2020

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: 03/31/2024
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.235
• Device Lot Number: 21244325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 11/12/2019; 01/27/2020
• Supplement Dates FDA Received: 12/06/2019; 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1