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

Model Number	MA50BM
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis.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.Product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported with a description of intraocular lens (iol) had scratches.The surgery was delayed by 10 minutes.The procedure was completed with backup product.Additional information received and stated that iol with scratch was explanted and a new one implanted in the same procedure.The patient was not hospitalized for the event.As per the surgeon opinion, the scratch probably occurred during forward shifting (haptics may have scratched the optics).Rather not a material defect, but a handling error.
Additional Manufacturer Narrative
The lens was not returned for analysis.Only the empty lens case was returned in the carton with the packaging inserts and the open peel pouch.There is no damage observed to the lens case or the locking arm mechanism.The lens case functions as intended.The associated cartridge and handpiece were not provided.It is unknown if qualified products were used.The company lens is only qualified for use with the company cartridge.Information was provided in the file that indicated the use of a non-qualified viscoelastic.The root cause for the reported complaint appears to be related to failure to follow the ifu (instructions for use).The file indicated the use of a non-qualified viscoelastic.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12890169
• Report Number: 1119421-2021-02262
• Device Sequence Number: 19172891
• Product Code: HQL
• UDI-Device Identifier: 00380650698490
• UDI-Public: 00380650698490
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2025
• Device Model Number: MA50BM
• Device Catalogue Number: MA50BM.180
• Device Lot Number: 15070322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTIVISC
• Patient Age: 62 YR
• Patient Sex: Male