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

Model Number SA60AT

Device Problems Entrapment of Device (1212); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.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 physician assistant reported that during an intraocular lens implant procedure, the lens became entangled in the iris blocking the entrance during injection.During manipulation to remove the iol from the iris, the haptic split.There was no patient harm.Additional information has been requested.

Manufacturer Narrative

The product was returned for analysis and the reported complaint was observed.Iol returned pressed down on three(3) posts of the lens case base.Solution is dried on both surfaces of the optic and haptics.One haptic is folded and is adhered to the optic surface with solution.The other haptic is broken/torn and is returned also adhered to the optic surface with solution.The file states the use of " company injector" which is not qualified to be used with the associated iol model.While we are unable to determine the origin of the damage/reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow dfu, as the customer states the use of non-qualified combination.The use of nonqualified combinations may result in delivery issues and/or damage.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: 10277157
• MDR Text Key: 199654964
• Report Number: 9612169-2020-00155
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.220
• Device Lot Number: 21256620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTREPID AUTOSERT IOL INJECTOR