MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	DIU300
Medical Device Problem Codes	Material Fragmentation (1261); Device Difficult to Setup or Prepare (1487); Ejection Problem (4009)
Health Effect - Clinical Code	Corneal Abrasion (1789)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6, patient information: unknown/not provided.Section d6a, if implanted, give date: not applicable as the iol was not implanted.Section d6b, if explanted, give date: not applicable as the iol was not implanted.Therefore, it was not explanted.Section h3, device evaluated by manufacturer: the device has not been returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The following was reported regarding the johnson and johnson (jnj) intraocular lens (iol).Upon inserting the cartridge into the clear corneal incision (cci) while advancing the lens, the first part of the iol entered the cci the doctor felt resistance.The doctor stopped and realized the toric iol was cracked in half.The first part of the iol was already in the anterior chamber (ac) while the second half of the iol was in the injector nozzle.The inserter was pulled out of the corneal incision, and the first half of the iol was retrieved from the anterior chamber.As the damaged iol opened up in the anterior chamber it lightly nicked the patients' endothelium, leaving a small 2-millimeter scratch.The broken optic and single haptic were removed.A backup iol was implanted successfully without additional complications.The patient is doing well.A photograph of the damaged lens was provided.Johnson and johnson requested the return of the product and the customer believes they have already returned it.No further information is available.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 24948574
• Report Number: 3012236936-2026-000105
• Device Sequence Number: 10092947
• Product Code: MJP
• UDI-Device Identifier: 05050474747586
• UDI-Public: (01)05050474747586(17)280526
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2026

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: DIU300
• Device Catalogue Number: DIU300U130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 05/20/2026; 06/23/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/26/2026; 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2025
• 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