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

Model Number	MA60MA
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11608234
• Report Number: 1119421-2021-00729
• Device Sequence Number: 16959503
• Product Code: HQL
• UDI-Device Identifier: 00380650699251
• UDI-Public: 00380650699251
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR