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

Model Number	DIB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a: not applicable, as the lens was not implanted.Section d6b: not applicable, as the lens was not implanted, hence not explanted.Section h3: the device was not returned for evaluation; 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 the review, if there is any further relevant information a supplemental medwatch will be filed.An attempts has 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
It was reported that during implantation of the preloaded monofocal intraocular lens (iol), model dib00, the tip of the inserter cracked as the lens was being delivered.A replacement lens of the same model and diopter was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review it was noticed the affected eye (right eye) was inadvertently not included in the initial medwatch report.The following section have been updated accordingly.Section b5: the affected eye was the patient's right eye.Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: (b)(6) 2026 section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint device reveal that the lens was received coated in viscoelastic residue.The lens was cleaned and no issues were identified.No handpiece was received for evaluation.The complaint issue "dc-cartridge tip cracked/damaged" could not be confirmed during product evaluation, and no issues were identified.Conclusion: based on the complaint investigation results, no product deficiency or product malfunction could be identified.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: 24710318
• Report Number: 3012236936-2026-000077
• Device Sequence Number: 6053320
• Product Code: HQL
• UDI-Device Identifier: 05050474731752
• UDI-Public: (01)05050474731752(17)281024
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: DIB00
• Device Catalogue Number: DIB00U0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2025
• 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