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

Model Number	DCB00
Medical Device Problem Codes	Break (1069); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by surgeon that a preloaded intraocular lens had scratches that were noticed after implantation.Viscoelastic was leaking out from the side of the cartridge.No additional information was provided.
Additional Manufacturer Narrative
Section d6b: if explanted, give date: section d6b: if explanted, give date: not applicable, remains implanted in the eye.Section e1: initial reporter: email address: unknown, information not provided.Section e1: initial reporter: telephone number: (b)(6).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.
Additional Manufacturer Narrative
Additional information: additional information indicated that the lens had some defects.As a result, the lens was removed and replaced with a backup lens during the same procedure.No additional information was provided.The following sections were updated accordingly: section b5: it was reported by surgeon that a preloaded intraocular lens had scratches that were noticed after implantation.Viscoelastic was leaking out from the side of the cartridge.Additional information indicated that the lens had some defects.As a result, the lens was removed and replaced with a backup lens during the same procedure.No additional information was provided.Section h6: health effect - impact code 2199 is no longer apply and are updated by code 4631 - more complex surgery.Device evaluation product evaluation was not performed because the product has not been received.If product is received after initial closure, the product investigation may be re-opened to complete the return investigation.The complaint issue reported could not be confirmed.Conclusion.Based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and 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: 22173138
• Report Number: 3012236936-2025-000161
• Device Sequence Number: 15443229
• Product Code: HQL
• UDI-Device Identifier: 05050474635876
• UDI-Public: (01)05050474635876(17)270402
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: DCB0000095
• Was Device Available for Evaluation?: No
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2024
• 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