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

Model Number SN60WF

Device Problems Break (1069); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during surgery, when the lens was implanted in the eye, the tip of the injector deformed the lens and the haptic was broken.The surgery was completed by replacing with the same model lens.

Manufacturer Narrative

The product was returned for analysis previously mentioned as sample was not returned.The product was returned for analysis and damage was observed to the lens.Iol returned positioned incorrectly in the iol case.Solution is dried on both surfaces of the optic and one haptic.One haptic is broken/torn and not returned, the other haptic is intact.The optic is torn/split-cut with a piece missing and scratched/marked-rejectable.Additional information: the file states that during the surgery, while the lens was implanted in the eye, the tip of the injector deformed the lens and the haptic was broken.The product investigation could not identify the root cause for the reported complaint.A malfunction has not been indicated or information provided that the lens was the cause of the event.The returned lens shows evidence of possible handling by the customer due to the presence of solution dried on both surfaces of the optic and one haptic.In addition to this, all lenses are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens 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.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL 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
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16303146
• MDR Text Key: 308865712
• Report Number: 9612169-2023-00101
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655093283
• UDI-Public: 00380655093283
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.245
• Device Lot Number: 25375743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male