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

Model Number	DCB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a monofocal intraocular lens (iol) was used in a surgery and the surgeon implanting the lens, noticed issues with the cartridge tip.The lens was used without incident and the patient was not impacted by the issue.Additional information received from customer indicated that the tip of the cartridge was defective, had a burr on it and was misshaped.The issue was noted right before insertion.The haptic or optic of the lens was not damaged.It was indicated that the damage was not due to use error.The procedure completed with the same iol and cartridge.No medical or surgical interventions required, and no patient injury or adverse outcomes reported.No further information was provided.
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown, information was requested but not provided.Section d6b: if explanted; give date: not applicable as the lens remains implanted.Section h3-other (81): the intraocular lens (iol) was not returned for evaluation as the lens remains implanted; 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.An attempt was made to obtain missing information; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes section d9: returned to manufacturer on: nov 13, 2023 section h3: device evaluated by manufacturer: yes device evaluation: the complaint handpiece was received inside of the original folding carton.No additional components or materials were received.Visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod advanced to the cartridge tip.The complaint cartridge was received with stress marks inside of the cartridge tip; however, stress marks are considered within specification for a used cartridge.Further inspection of the cartridge revealed that there was viscoelastic residue distributed throughout the length of the cartridge, suggesting that an appropriate amount of ophthalmic viscoelastic device (ovd)/balanced salt solution (bss) was used.The lens module was inspected 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.No lens was received.The complaint issue "cartridge tip cracked/damaged" was not identified during product evaluation.Conclusion: based on the investigation, no malfunction or product deficiency was identified.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: 18108469
• Report Number: 3012236936-2023-02847
• Device Sequence Number: 7671020
• Product Code: HQL
• UDI-Device Identifier: 05050474636019
• UDI-Public: (01)05050474636019(17)260113
• 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
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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: 01/13/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000165
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• 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