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

Model Number	DIB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) had the leading haptic twisted and unusually configuration.As a result, the lens was not implanted, and a backup lens was used.There was no contact with the patient¿s operative eye, no patient involvement, and no adverse effects reported.The customer provided additional information confirming that the haptic was damaged (twisted), while the cartridge tip remained undamaged, and no force was applied to deliver the lens.It was confirmed there was no patient contact.The damage was not attributed to user error, and the procedure was completed successfully using a backup intraocular lens.There was no patient injury and no unplanned medical or surgical interventions.The customer was asked to provide any photos or videos related to the event; however, none were available.No further information is available.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6: not applicable, as there was no patient involvement.Section d6a: if implanted, give date: not applicable, as there was no patient involvement.Section d6b: if explanted, give date: not applicable, as there was no patient involvement.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 to obtain additional information was conducted, however, there is no additional information available.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: 23846561
• Report Number: 3012236936-2025-000338
• Device Sequence Number: 18527598
• Product Code: HQL
• UDI-Device Identifier: 05050474731745
• UDI-Public: (01)05050474731745(17)280730
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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: DIB00
• Device Catalogue Number: DIB00U0195
• 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: 11/27/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• 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