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 Codes	Inflammation (1932); Blurred Vision (2137)
Date of Event	11/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following a cataract extraction with an intraocular lens (iol) implant procedure, lens haptics were pushing on peripheral iris causing inflammation.Patient experienced never being able to see well out of lens.The lens was explanted and replaced with another lens in a secondary procedure.During the procedure pars plana vitrectomy (ppv), ab-interno canaloplasty (abic), omni surgical system, goniotomy, yamane and limbal relaxing incisions (lri) were also performed.There was no patient harm and patient was not hospitalized as a result of this event.Patient¿s symptoms were resolved.Additional information was requested, but further no information was available.
Additional Manufacturer Narrative
The explanted lens was returned inside a plastic specimen jar.Solution and blood were dried on the lens.The lens was cleaned with klrp to further assess.One haptic was cracked in the distal area.The cracked haptic broke completely during cleaning.Product history records were reviewed and documentation indicated the product met release criteria.The root cause cannot be determined for the reported complaint of "explant, lens haptics were pushing on peripheral iris".The reported haptic issue could not be confirmed.It is not possible to confirm if haptics were pushing on iris.It is unknown if patient's eye anatomy contributed to the reported complaint.The explanted lens had a cracked haptic in the distal area.The haptic finished breaking during cleaning.It is unknown if the cracked haptic occurred upon implant or explant.The lens was reported implanted (b)(6) 2015.The lens was removed (b)(6) 2023.The company, 18.5 diopter lens was replaced with a non-company three-piece lens , 24.0 diopter.There have been no other complaints reported in the lot number.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: 16808112
• Report Number: 1119421-2023-00771
• Device Sequence Number: 12307424
• Product Code: HQL
• UDI-Device Identifier: 00380652535861
• UDI-Public: 00380652535861
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P880087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: MTA4U0
• Device Catalogue Number: MTA4U0.185
• Device Lot Number: 12382440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2015
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male