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

Model Number	DFR00V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section h3: other 81: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that there was a chunk missing out of tecnis synergy simplicity lens.Additional information received revealed that the lens was fully inserted in the patients right eye which was removed and replaced with another lens of same model during the same procedure.There were no patient injuries and no other medical or surgical interventions were required.No further information is available.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 8/15/2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint handpiece was received with a piece of the lens stuck inside of the cartridge tip and overridden by the plunger rod.The cartridge tip could also be observed to be cracked and have some of the stuck lens inside of the crack.Further inspection of the cartridge revealed that it was received with trace amounts of viscoelastic residue dispersed throughout the length of the cartridge, suggesting that an adequate amount of ovd was used.The handpiece was disassembled, and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.Visual inspection of the returned lens revealed that it was received cut in half (one half missing).The lens was cleaned, and the portion of the lens stuck inside of the cartridge was revealed to have been torn from the received portion of the lens.Based on the return condition of the lens, no further product evaluation could be performed.Conclusion: the complaint issue lens damaged was not confirmed during product evaluation.The observed iol torn is similar to the reported complaint issue.However, based on the complaint investigation results, the observed issues during product evaluation could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 17373090
• Report Number: 3012236936-2023-01889
• Device Sequence Number: 7036281
• Product Code: MFK
• UDI-Device Identifier: 05050474750456
• UDI-Public: (01)05050474750456(17)240420
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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: 04/20/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• 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: Female