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

Model Number	DCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: unknown, information not provided.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 e1: initial reporter: email address: unknown, information not provided.Section e1: initial reporter: telephone number: (b)(4).Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending 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 a haptic of the device was found to be broken or missing.There was no patient involvement, and no contact with the patient's eye occurred.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes section d9: returned to manufacturer on: 8/13/2025 section h3: device evaluated by manufacturer: yes device evaluation: visual inspection under magnification was performed and found that the lens was torn with one piece stuck in the cartridge and the other coated in viscoelastic residue and stuck to a piece of paper.The plunger rod was advanced to the lens stuck in the cartridge.Viscoelastic residue was observed to be distributed throughout the cartridge.No issues were identified with the cartridge, cartridge tip, lens module, device assembly, and plunger rod.The lens piece attached to the paper was cleaned and inspected; a scratch was observed.The lens portion in the cartridge could not be removed for further evaluation.No further evaluation was performed.Conclusion: the complaint issue "haptic damaged" was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be 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: 22734047
• Report Number: 3012236936-2025-000208
• Device Sequence Number: 15700702
• Product Code: HQL
• UDI-Device Identifier: 05050474636071
• UDI-Public: (01)05050474636071(17)270130
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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 Model Number: DCB00
• Device Catalogue Number: DCB0000195
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• 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