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

Model Number	MTA3U0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	06/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that, during intraocular lens (iol) implant procedure, the iol was not stable due to high vitreous pressure.The event occurred during right eye cataract surgery (with iol implant).Thus, dr.Decided to explant the lens and left aphakic for this patient.The surgery was completed on the same day.There is patient contact but no patient harm.Additional information was requested.
Additional Manufacturer Narrative
Information was provided that the reason for the explant of the iol was because it was not stable due to high vitreous pressure.Follow up was received from an hcp that the reason for the high vitreous pressure was due to "patient factor, not because of the iol.Based on the information provided, the event does not appear to be related to the product.The lens was explanted and the patient was left aphakic.No further information has been provided at this time.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received that the reason of high vitreous pressure was patient factor, not because of the iol.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.No damage is observed to the lens.The manufacturer internal reference number is: (b)(4).

• 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
• 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: 14897516
• Report Number: 1119421-2022-01445
• Device Sequence Number: 6187875
• Product Code: HQL
• UDI-Device Identifier: 00380650701268
• UDI-Public: 00380650701268
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P880087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2022

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: 10/21/2025
• Device Model Number: MTA3U0
• Device Catalogue Number: MTA3U0.190
• Device Lot Number: 15102620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 07/04/2022; 09/29/2022
• Initial Report FDA Received Date: 07/02/2022
• Supplement Report FDA Received Date: 07/30/2022; 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male