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	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6: unknown/asked but unavailable (asku).Section d6b: if explanted; give date: provided as (b)(6) 2025 however, the date is prior to the event date reported as 12/19/2025.Section e1: 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 the device history record and complaint trending 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 has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) was fully inserted when a scratch was observed at the haptic optic junction.It was also reported the lens was explanted.The patient's current status is unknown.No other information is available.
Additional Manufacturer Narrative
Correction: further clarification was provided confirming the lens was not explanted.The explant date provided was added inadvertently on the complaint form.No other information was provided.The following section has been updated accordingly: section h6: health effect, impact code: the code provided in the initial report 4629 is no longer applicable.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that the following fields were inadvertently not addressed in the initial mdr or in follow-up mdr report #1.Accordingly, the missing information has been documented in this supplemental mdr report as outlined below: section d6a: if implanted, give date: unknown; information was requested but not provided.Section d6b.If explanted, give date: not applicable, as there is no indication that the device was explanted.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: 24059831
• Report Number: 3012236936-2026-000017
• Device Sequence Number: 9494714
• Product Code: HQL
• UDI-Device Identifier: 05050474636088
• UDI-Public: (01)05050474636088(17)280822
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2026

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: DCB0000200
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 03/19/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/10/2026; 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2025
• 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