MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SA60WF

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturing device history records (dhr) were reviewed and shows that the product met specification prior to release and shows no other complaints in this lot.A product sample was not returned therefore, the reported event cannot be confirmed.The root cause of the reported event cannot be determined; however, should additional reportable information become available, a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56.(b)(4).

Event Description

A facility representative reported an intraocular lens that was "curled in shooter".There was contact with the patient but the procedure was completed with no patient harm reported.Additional information requested.

Manufacturer Narrative

Corrected and additional information was provided in b.2, b.5, d.10, and h.10.No supplemental report will be required as the additional information provided indicated that there was no patient contact.Had this information been received prior to submission of the initial medical device report the reported event would not have been reportable.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received states that there was no patient contact.

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10515252
• MDR Text Key: 207294666
• Report Number: 1119421-2020-01244
• 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: other
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• 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: SA60WF
• Device Catalogue Number: SA60WF.180
• Device Lot Number: 12641122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1