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

Model Number SN60WF

Device Problem Material Deformation (2976)

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

Event Date 08/05/2020

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

Event Description

A customer reported creases on an implanted intraocular lens (iol).There is currently no reported patient impact.Additional information was requested.

Manufacturer Narrative

Additional information provided in h.3., h.6., and h.10.The product was not returned for analysis.Only photo was returned.The returned photo shows implanted iol.There appears to be mark/line visible on the iol.The exact location of the line/mark cannot be confirmed.Based on our observations of the attached photo of the implanted iol, there appears to be mark/line visible on the iol.The exact location of the line/mark cannot be confirmed.A definitive determination of damage cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.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 the origin of the reported complaint as it was highlighted post implantation.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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
• MDR Report Key: 10417471
• MDR Text Key: 203812347
• Report Number: 9612169-2020-00180
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2020

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: SN60WF
• Device Catalogue Number: SN60WF.220
• Device Lot Number: 21259717
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 08/18/2020; 10/27/2020
• Supplement Dates FDA Received: 09/01/2020; 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1