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

Model Number	DIU450
Medical Device Problem Codes	Crack (1135); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: not applicable, as there was no patient contact with the device.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.Device evaluation: visual inspection under magnification was performed on the suspect product and found the lens was overridden and stuck in the tip of the cartridge with the trailing haptic not folded.The cartridge was observed to have a stress mark that extended to damage on the cartridge tip with ophthalmic viscoelastic device (ovd) observed inside the cartridge.The lens module, plunger rod, and handpiece were inspected, and no issues were identified.The lens could not be removed from the cartridge for further evaluation.No further evaluation was performed.The complaint issue "stuck in cartridge" was identified during product evaluation.The complaint issue "cartridge crack" was not identified during evaluation.The observed "cartridge tip cracked/damaged" is similar to the reported complaint issue.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no other complaints were received for this po.Conclusion: based on the investigation, no malfunction or product deficiency was identified.An attempt 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 crack in the cartridge of a preloaded monofocal toric intraocular lens (iol) was noticed and that the lens did not deploy.Patient contact was confirmed in connection with this incident.No further information provided.
Additional Manufacturer Narrative
Corrected data: in review, it was noted that the initial mdr report incorrectly marked "device evaluation" in field h2; that field should have been left blank.This supplemental mdr corrects that error.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 24063611
• Report Number: 3012236936-2026-000010
• Device Sequence Number: 13328794
• Product Code: MJP
• UDI-Device Identifier: 05050474749054
• UDI-Public: (01)05050474749054(17)260417
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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 Expiration Date: 04/17/2026
• Device Model Number: DIU450
• Device Catalogue Number: DIU450U275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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