MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS SYNERGY SIMPLICITY; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DFW225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that preloaded lens (iol) was defective.There was no patient contact.Additional information states lens haptic or optic got damaged by the plunger itself while it was being advanced by the tech.No further information available.
Additional Manufacturer Narrative
Age or dog, weight, ethnicity: not needed as there was no patient contact or impact.Date of event: unknown, not provided.If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted.Hence, not explanted.Attempts have been made to obtain missing information; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section b3: date of event: (b)(6).2021 section d9: device available for evaluation ¿ yes, returned to manufacturer on 12/15/2021 section h3: device evaluated by manufacturer ¿ yes device evaluation: visual inspection under magnification revealed trace amounts of viscoelastic residue inside of the cartridge.Further observation revealed that the cartridge was damaged and that a lens was received stuck inside of the cartridge.The handpiece was disassembled and the assembly was inspected; presenting with no issues.The complaint lens was removed and cleaned; presenting with lens damage as well as haptic damage (bent).The complaint issue could be confirmed; however, this may be attributed to an inadequate amount of ovd and excessive force applied to the lens, suggested by the trace amount of viscoelastic residue inside of the cartridge and the cartridge damage, and cannot be confirmed to be related to a manufacturing issue.Therefore, no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaint was received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SYNERGY SIMPLICITY
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12776833
• Report Number: 2020664-2021-08056
• Device Sequence Number: 6025779
• Product Code: MFK
• UDI-Device Identifier: 05050474751712
• UDI-Public: (01)05050474751712(17)240303
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2024
• Device Model Number: DFW225
• Device Catalogue Number: DFW225U130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown