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 Date 06/21/2019

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.(b)(4).

Event Description

A customer reported an intraocular lens (iol) was defective.There was no reported patient contact.Additional information was requested.

Manufacturer Narrative

The product was returned for analysis and the reported damage was observed.Additional observations were as follows: iol returned positioned incorrectly and pressed against one (1) post of iol case base.Solution is dried on the iol.The optic is cracked/fractured and scratched/marked-rejectable with loose fibers & particulate.We are unable to determine the root cause for the reported complaint - it was defective.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: 8776641
• MDR Text Key: 150680820
• Report Number: 9612169-2019-00189
• 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: other
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

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: SN6AT3
• Device Catalogue Number: SN6AT3.195
• Device Lot Number: 21223706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1