MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFAT30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	05/07/2021
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 physician reported that during the intraocular lens (iol) implantation procedure, upon lens insertion it was noted that the trailing haptic was fully detached from the lens.The lens was cut, removed and replaced during initial procedure.The surgery was prolonged as the patient experienced corneal edema and had suture as additional procedure.The suture was removed on a later date and the prognosis was good.
Additional Manufacturer Narrative
The file indicates, the use of a non-qualified cartridge.The company cartridge is only qualified for this company lens with a diopter range of 6.0 - 25.0.The root cause is most likely, a failure to follow the dfu.The ifu instructs that 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).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11992822
• Report Number: 1119421-2021-01207
• Device Sequence Number: 922862
• Product Code: MFK
• UDI-Device Identifier: 00380652418829
• UDI-Public: 00380652418829
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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: 04/01/2025
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.260
• Device Lot Number: 15062996
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 08/02/2021
• 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: DUOVISC; MONARCH III CARTRIDGE D; MONARCH III INJECTOR; DUOVISC; MONARCH III CARTRIDGE D; MONARCH III INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR