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

Model Number SN6AT4

Device Problem Defective Component (2292)

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

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that during a cataract extraction with intraocular lens (iol) implant procedure, that there was a defect on the iol before inserting the iol into the cartridge.The surgeon used a backup iol.There was no risk to the patient.No further information is available.

Manufacturer Narrative

Product evaluation: the product was returned for analysis and damage was observed to the lens.Additional observations were as follows: iol returned positioned incorrectly in the iol case and is pressed down into well area of iol case base, resulting in deformation of the iol.Solution is dried on the iol.One haptic is broken/torn and is returned.The optic is scratched/marked rejectable.We are unable to determine the root cause for the reported complaint "defect on the lens".The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on the iol.In addition to this, all iols 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.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• MDR Report Key: 9862339
• MDR Text Key: 186734335
• Report Number: 9612169-2020-00108
• Device Sequence Number: 1
• Product Code: MJP
• 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: 08/05/2020

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: 10/31/2020
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.100
• Device Lot Number: 21145055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1