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

Model Number SA60WF

Device Problem Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2019

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 a folding issue with an intraocular lens (iol).There was reported patient contact but no reported patient impact.Additional information was requested.

Manufacturer Narrative

The product was returned for analysis.Additional information: the lens was returned just past the loading area in a iii (d) cartridge.Inadequate viscoelastic is observed in the cartridge.The trailing haptic is extended back behind the lens.The leading haptic is folded back toward the optic.The cartridge has no evidence of being placed into a handpiece.The cartridge was cleaned for further evaluation.The lens was removed and placed in the lens case.Top coat dye stain testing was conducted with acceptable results.The root cause for the reported complaint appears to be related to a failure to follow the dfu.No viscoelastic was observed past the lens.The dfu instructs to fill the cartridge with viscoelastic before loading the lens.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage or delivery issues.Top coat dye stain testing was conducted with acceptable results.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 8607479
• MDR Text Key: 144971155
• Report Number: 9612169-2019-00100
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

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: 07/31/2023
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.225
• Device Lot Number: 21224952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/14/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1