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

Model Number	DCB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a single piece preloaded monofocal intraocular lens (iol) was scratched.There was no patient contact.The product is not available since it was discarded.No further information was provided.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: unknown as there is no patient contact.Section d6a.If implanted, give date: not applicable, as there was no patient contact.Section d6b.If explanted, give date: not applicable, as there was no patient contact.Section h3: the device was not returned for evaluation as it was discarded; 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.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information was received and stated that the tip of the cartridge was not damaged.No damages in the haptic and optic.The user did not apply force when the iol was being delivered.The event was not observed during handling.The device did not cause or contribute to the event.The procedure was not completed with the same iol but a replacement was used instead.No issues with patient outcome.Healthcare provider information was also provided; therefore, section e1 is being updated in this supplemental report.No further information was provided.The following fields were updated accordingly: section e1: title (e.G., mr., ms.): dr.Section e1: first/given name: (b)(6) section e1: last name: (b)(6) section e2: health professional?: yes section e2: occupation: physician 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: 24416802
• Report Number: 3012236936-2026-000050
• Device Sequence Number: 17611924
• Product Code: HQL
• UDI-Device Identifier: 05050474635852
• UDI-Public: (01)05050474635852(17)261104
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: DCB0000085
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2023
• 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