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

Model Number	DCB00
Medical Device Problem Codes	Break (1069); Ejection Problem (4009)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4, a5, a6: information unknown/not provided.Section d6a: if implanted, give date: not applicable, as the lens was not implanted.Section d6b: if explanted, give date: not applicable, as the lens was not implanted.Therefore, it was not explanted.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, complaint trending, for this device will be performed.Completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section h6: health effect - impact code: 4625 incision enlarged.Attempts have been made to obtain missing information.However, the account did not provide the information.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) was defective and had an unfolding problem during a procedure.The lens was partially inserted into the patient's right eye, that necessitated an incision enlargement and suturing.Another johnson & johnson lens (same model and diopter) was implanted as a replacement.Through follow up, it was confirmed there was lens damage and the lens was partially inserted.An incision enlargement and suture were required.Additional information was provided clarifying that the suture was prophylactically used to prevent a leak.The implantation of the replacement lens was done successfully.No other information was provided.

• 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: 22898296
• Report Number: 3012236936-2025-000226
• Device Sequence Number: 8896726
• Product Code: HQL
• UDI-Device Identifier: 05050474635883
• UDI-Public: (01)05050474635883(17)260810
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2025

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 Expiration Date: 08/10/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000100
• 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: 08/01/2025
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2023
• 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: Male