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

Model Number	DIU150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded toric intraocular lens (iol) was wrinkled and could not be used.There was no patient contact.The type of ophthalmic viscosurgical device (ovd) that was used is unknown.No further information was provided.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: not applicable, as there was no patient contact.Section b3: date of event: unknown; requested but not provided.The best estimate date is on or prior to dec 12, 2025.Section d6a.If implanted, give date: not applicable, as there was no patient contact.Section d6b.If explanted, give date: not applicable, as there was no patient contact.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.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional data: the product was received for evaluation.Device evaluation: visual inspection under magnification was performed on the suspect product and found the plunger rod fully advanced with viscoelastic residue observed throughout the cartridge.No issues were identified with the lens module, device assembly, and plunger rod advancement; however, the plunger rod tip was observed to be bent.The lens was received coated in viscoelastic residue.The lens was cleaned revealing scratches on the lens.No further evaluation was performed.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.The following fields were updated accordingly: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jan 07, 2026.Section h3: device evaluated by manufacturer: yes.Corrected data: based on further review of the complaint file, it was noted that an incorrect date was inadvertently entered in section ""h4 - device manufacture date"" of the initial medwatch report.This supplement is being submitted to correct that information.The following section has been updated accordingly: section h4: may 26, 2025.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: 23976917
• Report Number: 3012236936-2026-000006
• Device Sequence Number: 10609317
• Product Code: MJP
• UDI-Device Identifier: 05050474746398
• UDI-Public: (01)05050474746398(17)280527
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: DIU150
• Device Catalogue Number: DIU150U125
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/19/2026
• 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