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

Model Number	DCB00
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as there was no patient contact with the product.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) would not push out of the inserter and the haptic was broken.There was no contact with the patient's operative eye.
Additional Manufacturer Narrative
Additional information received revealed following information and following information and corrections are being captured in this report: section b5 (additional information): additional information revealed that the lens was discarded.Section e1: email address: (b)(6).Section e1: telephone number: (b)(6).Section h3: other 81: the device was not returned for analysis as the lens was discarded.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.Section h6: type of investigation: 4115 - device discarded.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: jun 22, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the handpiece was received with the plunger rod in the retracted position.The cartridge tip could be observed to be deformed and cracked and the cartridge could be observed to be deformed as well.A portion of detached haptic was observed stuck to the outside of the cartridge (rest of the lens not received).The handpiece was disassembled and the assembly was inspected, no issues that could contribute to advancement issues could be identified.Conclusion: the reported complaint issues were not confirmed.However, the observed issue is similar to the one of the complaint issue and could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.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: 14581897
• Report Number: 3012236936-2022-01443
• Device Sequence Number: 11267798
• Product Code: HQL
• UDI-Device Identifier: 05050474636316
• UDI-Public: (01)05050474636316(17)230303
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 09/07/2022

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: 03/03/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000315
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 06/09/2022; 08/15/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 07/01/2022; 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2020
• 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 Age: 67 YR
• Patient Sex: Male