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

Model Number	MA60AC
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that following an intraocular lens (iol) implant procedure, patient planned for membractomy and during the procedure opacity is observed on the lens which was implanted 5 months before.The patient was a pediatric patient of age around 1 year and the lens was exchanged for similar lens model in the same procedure.
Additional Manufacturer Narrative
Additional information was provided in d.9.,h.3.,h.6 and h.11.The intra ocular lens (iol) was returned in a stoppered vial submerged in ophthalmic viscosurgical device (ovd).The lens was removed from the vial.One haptic had been pulled from the optic, returned.The haptic has a bulbous tip, which indicates a weld was conducted during manufacturing.The lens was cracked in the haptic insertion area of the removed haptic.The optic was scratched on the posterior surface.No opacities observed.The lens was cleaned with klrp (klotho-related protein).Two areas of scruff marks were observed near the optic edges.This damage has the appearance of damage caused by an instrument used to grasp the lens.This damage may have been interpreted as opacities.A video was provided which showed the removed lens being held beside another company model lens and being rinsed with liquid.The explanted lens had a hazy appearance.The returned lens did not have this hazy appearance.It was reported the patient was undergoing a membranectomy.The reported opacity may have been related to this issue.The root cause for the reported opacity could not be determined.No opacities were observed on the returned lens.The returned lens had damage that may have been interpreted as the reported opacities.The reported opacity was stated to be observed during a membranectomy.It is unknown if the observed opacity may have been related to this issue.The video showed a hazy appearance on the explanted lens.The lens was clear when returned.Power and resolution were verified, and the lens met specification.The lens was reported to have been implanted in a pediatric patient of age around 1 year.Per the instructions for use (ifu) the company model posterior chamber intraocular lens is indicated for the replacement of the human lens to achieve visual correction of aphakia in adult patients.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: 19124851
• Report Number: 1119421-2024-00735
• Device Sequence Number: 20738395
• Product Code: HQL
• UDI-Device Identifier: 00380652552660
• UDI-Public: 00380652552660
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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 Model Number: MA60AC
• Device Catalogue Number: MA60AC.270
• Device Lot Number: 15484967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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: 12 MO
• Patient Sex: Male