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

Model Number	MA60MA
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.A photo was provided of the eye.Blood is observed on the lower right side of the eye.What appears to be a broken multi-piece haptic is observed in the front of the eye.The haptic insertion area of the iol is not visible.Unable to determine if the optic is damaged.It was indicated the haptic was observed during a surgery to reposition the lens.Product history records were reviewed and documentation indicated the product met release criteria.There are no other complaints in this lot.The customer stated qualified product were used; however, the specific product information was not provided for verification.The lens model is only qualified for use in the one specific company cartridge.The root cause for the reported dislocated lens and the broken haptic observed during the repositioning surgery could not be determined.The lens remains implanted.The photo does not allow for a determination of if the haptic was actually broken or pulled out of the optic.Haptic manufacturing is a validated process with multiple inspections to verify the quality of the produced haptic material.These inspections include a verification of the dimensional accuracy, tensile strength, flexibility and cosmetic appearance.The inspections ensure that the material meets all required specifications before it is allocated for use.During implantation of the company iol, an company qualified delivery system and ophthalmic viscosurgical device (ovd) combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during surgery for repositioning intraocular lens (iol) in a highly myopic patient, iol haptic was observed in front of the iris and loose.The physician removed the iol haptic and repositioned it, as he did not have a new iol to replace.Additional information was received from initial reporter, who reported that during an intraocular lens (iol) implant procedure, the haptic inside the eye was broken and the iol decentralized.In the second intervention, the iol was repositioned with no patient harm.The patient's current condition in relation to the harm/symptom was recovered.

• Brand Name: ACRYSOF MULTIPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12624881
• Report Number: 1119421-2021-01925
• Device Sequence Number: 4344323
• Product Code: HQL
• UDI-Device Identifier: 00380650699244
• UDI-Public: 00380650699244
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2026
• Device Model Number: MA60MA
• Device Catalogue Number: MA60MA.010
• Device Lot Number: 15124824
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR