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

Model Number	DIB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4 and a5: unknown asked but not available.Section d6a: if implanted, give date: not applicable, as there is no indication that the lens was implanted.Section d6b: if explanted, give date: not applicable, as there is no indication that the lens was implanted.Section h3: other 81: the device was not returned for evaluation as the lens remain implanted in the eye.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 tecnis simplicity eyhance pre-loaded intraocular lens (iol) was fractured per surgeon which was not related to use error.No medical or surgical intervention was required.Another lens of same model and diopter was implanted.No further information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes section d9: returned to manufacturer on: november 6, 2023 section h3: device evaluated by manufacturer: yes device evaluation: visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod overriding the lens.The complaint cartridge was received with the lens stuck inside of the cartridge and with the cartridge tip bulging around the lens.Further inspection of the cartridge revealed that there was not viscoelastic residue distributed throughout the length of the cartridge, suggesting that an inadequate amount of ovd/bss may have contributed to the complaint issue.The lens module was opened and, no marks that would indicate that the plunger rod advanced incorrectly could be identified.The handpiece was disassembled and, the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.Inspection of the lens inside of the cartridge revealed that one haptic was detached.The lens could not be retrieved from the cartridge; therefore, no further product evaluation could be performed.Conclusion: the complaint issue "lens damaged" was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.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: 18034382
• Report Number: 3012236936-2023-02727
• Device Sequence Number: 8213691
• Product Code: HQL
• UDI-Device Identifier: 05050474731653
• UDI-Public: (01)05050474731653(17)250812
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: 08/12/2025
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0150
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• 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: 69 YR
• Patient Sex: Male