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

Model Number	MA50BM
Medical Device Problem Codes	Off-Label Use (1494); Malposition of Device (2616)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/20/2021
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 pharmacist reported that following an intraocular lens (iol) implant procedure in the (b)(6) years old child, the patient experienced several opacities of the capsular bag and the implant that required 3 repeat surgeries.The eye never recovered well at the visual level despite a well conducted amblyo-therapy.A slit lamp examination found a subluxated iol.In front of the opacification of the of the iol, with a decrease of the vision and an intra-ocular pressure at 21.The iol was explanted and did not implanted with the new iol considering the poor visual prognosis.Additional information has been requested.
Additional Manufacturer Narrative
The lens surface appears to have been altered.Information was provided that the facility disinfected the iol (intraocular lens) with an unknown device detergent-disinfectant and bleach.This appears to have damaged the lens surface.Due to the exposure to an unknown chemical and harsh bleach an evaluation for the reported opacification cannot be conducted.The lens was returned in pieces inside a plastic container.Solution was dried on the lens.One haptic was broken in the distal area (returned) and the distal tip area (not returned).The optic was cut into two pieces.The cut optic pieces have multiple cracks near the cut areas.Both cut optic pieces have deep scratches and scuff marks in the shape of an instrument used to grasp the lens.The lens damage observed is typical of insertion and removal.The root cause for the reported events could not be determined.The lens was retuned cut into pieces.The lens surface appears to have been altered.Information was provided that the facility disinfected the iol with an unknown device detergent-disinfectant and bleach.This appears to have damaged the lens surface.Due to the exposure to an unknown chemical and harsh bleach an evaluation for the reported opacification cannot be conducted.Power and resolution evaluation was attempted using the larger lens portion.Exact focal length/resolution measurements could not be obtained due to the extensive optic damage.However, the lens is within the 28.5 diopter range.Additional information was provided that the lens was explanted from a 4-year old child.The ifu (instructions for use) states; company uv-absorbing acrylic foldable multipiece posterior chamber lenses are optical implants for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery.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: 12829565
• Report Number: 1119421-2021-02171
• Device Sequence Number: 1441606
• Product Code: HQL
• UDI-Device Identifier: 00380650698704
• UDI-Public: 00380650698704
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: MA50BM
• Device Catalogue Number: MA50BM.285
• Device Lot Number: 12393391
• 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: 10/26/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2015
• 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: 4 YR
• Patient Sex: Female