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

Model Number	MN60AC
Medical Device Problem Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	06/01/2021
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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health professional reported that during an intraocular lens (iol) implant procedure, the haptic broke in the eye.The patient required large opening with stitches.Additional information has been requested.
Event or Problem Description
Additional information was requested and received stating that the intraocular lens was broken (earlier reported as haptic broken) in eye as there was a loading issue (wrong cartridge used) and wrong placement of haptics in the cartridge.The intraocular lens was removed and replaced with another lens during the initial procedure.No post-operative complications were reported.
Additional Manufacturer Narrative
Corrected information was reported in b.5., d.1., d.4., d.5.And h.4.Additional information was reported in b.5., d.9., d.10., h.3., h.6.And h.10.The carton with the label set for the reported lens was returned.A clear opened pouch similar to the provided photo was in the carton.No lens was found in the pouch or the carton.A photo was provided of the carton end cap with the visible serial number.A lens can be observed loose in a clear front pouch.Both haptics are still attached and do not appear damaged.Unable to determine if the optic is damaged from the photo.Product history records were reviewed and documentation indicated the product met release criteria.A non-qualified company cartridge was indicated.The company lens is only qualified for use in the qualified company cartridges.The root cause for the reported damage may be related to a failure to follow the ifu.The customer indicated the use of a non-qualified company cartridge.The company lens is only qualified for use in the qualified company cartridges.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The reported damage could not be verified by the provided photo.The lens was not found, when the carton was received.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
• MDR Report Key: 12023597
• Report Number: 1119421-2021-01232
• Device Sequence Number: 14537705
• Product Code: HQL
• UDI-Device Identifier: 00380652332736
• UDI-Public: 00380652332736
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 03/31/2024
• Device Model Number: MN60AC
• Device Catalogue Number: MN60AC.210
• Device Lot Number: 12706196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/26/2021
• 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: MONARCH II IOL INJECTOR; MONARCH III IOL CARTRIDGE C; UNSPECIFIED OVD; VISCOSHIELD OVD
• Outcome Attributed to Adverse Event: Required Intervention