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

Model Number	MA60AC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	07/08/2021
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.No other complaints for lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported an intraocular lens (iol) implant procedure was completed uneventfully and the patient was discharged one day following the surgery.The patient experienced blurred vision a few days later and a dislocation of the iol was noted during a follow-up consultation.The patient underwent another operation for removal and replacement of the defective product.The event resolved following the secondary procedure.The sample is available.No further information is expected.
Additional Manufacturer Narrative
The lens was returned wrapped in woven white gauze material.The woven material was damp and folded.The optic was scratched.The optic also has debris consistent with being held in gloved hands.Both haptics were removed from the haptic insertion areas.Both haptics have a bulbous end, indicative that a weld was performed during the manufacturing process.One haptic was bent in the distal area and broken at the distal tip.The other haptic was broken in the distal tip.The optic was cleaned with lphse for further evaluation.A power and resolution test was conducted.The optical resolution was acceptable.The optic met specification for focal length equaling a 14.0 diopter.Several photos were provided of the optic being held multiple times in gloved hands.The photos match the condition of the explanted lens.Associated products were not provided.It is unknown if qualified products were used.The company lens is only qualified for use in the company cartridges.The explanted lens was returned with optic scratches, both haptics pulled from the optic and both haptics broken.The optic has surface cosmetic evidence consistent with being held in a gloved hand.Several photos were provided of the optic being held multiple times in gloved hands and laying on white gauze.The photos match the condition of the explanted lens.The lens was cleaned with lphse for further evaluation.A power and resolution test was conducted.The optical resolution was acceptable.The lens met specification for focal length equaling a 14.0 diopter.It is unknown if qualified associated products were used with the lens.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met companies release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The file indicated that the surgery was completed uneventfully and the patient was discharged 1 day after the surgery.However, the patient experienced blurred vision a few days later.Dislocation of the product was noted during follow-up consultation.Patient underwent another operation on (b)(6) for removal of the lens.The replacement lens model and diopter information was not provided.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that, haptic disconnected with the optic and which mainly caused the lens dislocation.The patient also stated that the secondary surgery caused the reduction of endothelial cell count.

• 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: 12594214
• Report Number: 1119421-2021-01908
• Device Sequence Number: 4460613
• Product Code: HQL
• UDI-Device Identifier: 00380652552400
• UDI-Public: 00380652552400
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 05/31/2023
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.140
• Device Lot Number: 12632217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/10/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACRYSOF IOL
• Outcome Attributed to Adverse Event: Required Intervention