MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number	DIB00
Medical Device Problem Codes	Break (1069); Failure to Fold (1255)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight, ethnicity: not applicable, as there was no patient contact.If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted.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 the preloaded intraocular lens (iol) haptic was folded and sticking out of the folder and bent.There was no use error.The event was observed during handling but prior to insertion into the eye.There was no patient contact and no patient injury.The procedure was completed successfully using a back-up lens.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: feb 6, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint handpiece was received with the lens stuck inside of the cartridge and with the plunger rod overriding the lens.The lead haptic could not be observed to be unfolded.The handpiece could not be disassembled because the plunger rod was stuck with the lens; however, the lens module was opened and inspected for damage and flashing that could contribute to the observed and/or complaint issues and none could be identified.Inspection of the external assembly revealed no issues.Because the handpiece could not be disassembled the lens could not be removed from the cartridge and inspected; however, lens damage could be identified from inspecting the lens inside of the cartridge.The complaint issues ¿iol: dc-haptic damaged¿ and ¿iol : dc-lead haptic not folded¿ were not confirmed.The other observed issue of ¿dc-lens damaged¿ found during the product evaluation is related to the code of ¿iol : dc-haptic damaged¿, however, could not be confirmed to be related to a manufacturing or design issue.The remaining observed issues found during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.Corrected data: upon further review it was noted that "g4" field which should have been populated with "no" was inadvertently left blank on the initial mdr; therefore, the information has been corrected in this supplemental mdr report and the following fields have been updated accordingly: section g4: combination product: no.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16267690
• Report Number: 3012236936-2023-00187
• Device Sequence Number: 6973244
• Product Code: HQL
• UDI-Device Identifier: 05050474731622
• UDI-Public: (01)05050474731622(17)240613
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/01/2023

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: 06/13/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2021
• 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