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

Model Number SN6AT3

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A facility representative reported a defective intraocular lens (iol).Additional information has been requested.

Manufacturer Narrative

Evaluation summary: the product was returned for analysis and damage was observed to the lens.Additional observations were as follows: iol returned pressed down into well area of iol case base, resulting in deformation of the iol.A significant amount of solution is dried on both surfaces of the optic and haptics.Both haptics are adhered to the optic surface in a folded position with solution.The optic is cracked/fractured.The optic is also bent/deformed.We are unable to determine the root cause for the reported complaint.The returned iol shows evidence of possible handling by the customer due to the presence of a significant amount of solution dried on both surfaces of the optic and haptics.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 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 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: 9721010
• MDR Text Key: 183564889
• Report Number: 9612169-2020-00061
• 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: 05/21/2020

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 Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.255
• Device Lot Number: 21250854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 04/27/2020
• Supplement Dates FDA Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1