MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ANTERIOR CHAMBER PMMA SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	MTA4U0
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not been evaluated yet.Device has not made it to the manufacturing site.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.Results from the product history record review 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 healthcare professional reported that during implantation of an intraocular lens (iol) the lens found defective with no patient adverse event.Additional information was requested.
Additional Manufacturer Narrative
Additional information reported in b.5.And h.10.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a reportable malfunction.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and stated that unsterilized lens and manipulation issue with no impact to the patient.

• Brand Name: ANTERIOR CHAMBER PMMA SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12319616
• Report Number: 1119421-2021-01561
• Device Sequence Number: 16818372
• Product Code: HQL
• UDI-Device Identifier: 00380652535861
• UDI-Public: 00380652535861
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P880087
• 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): 09/02/2021

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: 10/31/2024
• Device Model Number: MTA4U0
• Device Catalogue Number: MTA4U0.185
• Device Lot Number: 12759211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1