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	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: unknown, information was requested but not provided.Section e1: first name: unknown; requested but not provided.Section d6a: if implanted, give date: not applicable, the lens was not implanted.Section d6b: if explanted, give date: not applicable, the lens was not implanted.Hence, not explanted.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 this review, if there is any further relevant information, a supplemental medwatch will be filed.Attempts have been made with the customer to obtain additional information, however, to date, the information has not been provided.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 identified with an issue during a procedure.When ejecting the lens with the simplicity injector, it was noted that the leading haptic was deformed.As a result, the lens was not completely inserted into the patient's eye.No harm was caused to the patient.The simplicity injector was removed, a replacement lens was requested, and the affected lens was disposed of in the trash.It was noted that there was patient contact.No further 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: 22999911
• Report Number: 3012236936-2025-000239
• Device Sequence Number: 13034053
• Product Code: HQL
• UDI-Device Identifier: 05050474636088
• UDI-Public: (01)05050474636088(17)280613
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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: 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: 08/14/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2025
• 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