MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number MA60MA

Device Problem Device Damaged Prior to Use (2284)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/15/2021

Event Type  Injury  

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.(b)(4).

Event Description

A surgeon reported that during a cataract extraction with intraocular lens (iol) implant procedure, after opening the box with the iol, was found that the optical part was damaged.Another iol was ordered.The surgery day was postponed to another day.The iol was unpacked according to the instructions.Additional information was provided that there was no contact between the iol and the patient.The defect was detected while opening the container.The patient's natural lens was removed before the defect was found.The operation was postponed to the next day.A similar lens was implanted that next day.The patient's condition is good.

Manufacturer Narrative

Product evaluation: the product was not returned.A photo was provided of the lens incorrectly in the lens case.There appears to be marks/scuffs on the optic of the lens.Due to the poor quality of the photo, the nature of the damage and the presence of viscoelastic cannot be determined.Product history records were reviewed and the documentation, indicated the product met release criteria.Based on our observation of the attached photo, the lens appears to be damaged.The presence of clinical solution on the lens cannot be confirmed.It is difficult to make a determination, of handling/ damage without evaluation of the physical sample.A final root cause cannot be determined, based on available information.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11608234
• MDR Text Key: 243568972
• Report Number: 1119421-2021-00729
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380650699251
• UDI-Public: 00380650699251
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: MA60MA
• Device Catalogue Number: MA60MA.020
• Device Lot Number: 12550467
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR