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

Model Number	DIB00
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient gender: both male and prefer not to disclose were marked on the reporting form.Date of event: unknown as information was not provided, the best estimate date is (b)(6) 2023.Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted, therefore not explanted.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 during product handling and prior to insertion the pre-loaded dib00 intraocular lens (iol) had loading issues, bent/broken haptic, and was stuck in the cartridge.Cartridge tip had patient contact but the lens was not inserted into the patient¿s ocular sinister (left eye).Outcome does not significantly interfere with activities of daily life and the patient has recovered.No further information is available.
Additional Manufacturer Narrative
Correction: additional information was received with device return.The following fields were updated accordingly: section a-2 patient date of birth: (b)(6) 1957.Section b-3 date of event: (b)(6) 2023.It was also indicated on the patient implant card, the patient's ocular dexter (right eye) was affected.Additional information: section d-9: device available for evaluation: yes section d-9: date returned to manufacturer: 07-mar-2023 section h-3: device evaluated by manufacturer: yes device evaluation: the complaint handpiece was received inside of the original folding carton.Visual inspection under magnification revealed that the complaint handpiece was received with the lens stuck at the gap where the cartridge and lens module meet.The lens could also be observed to be overridden by the plunger rod as well.The handpiece was disassembled, and the assembly was inspected, no issues that could cause or contribute to the complaint or observed issues could be identified.Viscoelastic residue could be observed inside of the lens module as well.The lens was removed from the cartridge and cleaned, revealing damage consistent with a lens that was overridden as well as a chip on the spare tire of the lens.The trailing haptic could also be observed to be detached.Complaint issue " dc-stuck in cartridge" and ¿dc-device advancement issue¿ were identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.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: 16446317
• Report Number: 3012236936-2023-00495
• Device Sequence Number: 12227407
• Product Code: HQL
• UDI-Device Identifier: 05050474731998
• UDI-Public: (01)05050474731998(17)240507
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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: 05/07/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0315
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2021
• 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: Prefer Not To Disclose
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White