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

Model Number	DIB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4, a5, a6: unknown, information was requested but not provided.Section d6b: n/a (not applicable).The intraocular lens remains implanted.Section h3: the device was not returned for evaluation as the lens remains implanted; 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 to obtain missing information; however, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A surgeon reported that following implantation of a preloaded monofocal intraocular lens (iol), a peripheral ¿graze¿ consistent with contact from the plunger was observed on the lens.The graze was visible intraoperatively but was removed during the irrigation and aspiration (i&a) procedure.The device had been prepared with balanced salt solution and left in the dwell state for three minutes prior to advancing the plunger.The iol remained implanted and was not explanted.The surgeon reported encountering this issue repeatedly across two separate accounts.Additional information confirmed that that the cartridge tip and the haptic/optic were not damaged and that the event was not attributable to use error.There were no reported postoperative visual issues related to the graze, no surgical or medical intervention was required, and no patient injury was reported.All observed graze material was removed at i&a.No further information was provided.This submission covers the incident involving dib00, sn (b)(6).Two additional reports are being submitted for similar incidents reported at two different accounts.

• 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: 23560495
• Report Number: 3012236936-2025-000301
• Device Sequence Number: 10148911
• Product Code: HQL
• UDI-Device Identifier: 05050474731547
• UDI-Public: (01)05050474731547(17)270927
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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: DIB00U0095
• 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: 10/21/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• 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 Age: 67 YR
• Patient Sex: Female