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

Model Number	DIU150
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2: age and/or date of birth: unknown/not provided.Section a4: weight: unknown/not provided.Section a5: ethnicity: unknown/not provided.Section a6: race: unknown/not provided.Section d6a: if implanted, give date: not applicable, as lens was inserted and then removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was inserted and then removed/replaced during the same procedure.Device evaluation: the device was not returned to the manufacturing site; therefore, product testing could not be performed, and the reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no similar complaints for this po number have been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Attempts were made to obtain the missing information; however, no further information was provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that when inserting the preloaded toric monofocal intraocular lens (iol) into the patient¿s right eye, both the surgeon and scrub technician observed that the lens was coming out of the loader backwards.The lens was immediately removed and another lens was inserted.There was patient contact.Through follow up, it was learned that the lens was fully delivered and then removed and replaced during the same procedure.There was no patient injury.No medication outside the standard of care was prescribed.It is unknown if any unplanned surgical intervention or additional surgical maneuvers outside the normal standard of practice were required or if there are any planned surgical interventions.The patient status is unknown.No further information was provided.

• 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: 23838658
• Report Number: 3012236936-2025-000324
• Device Sequence Number: 9817160
• Product Code: MJP
• UDI-Device Identifier: 05050474746534
• UDI-Public: (01)05050474746534(17)270207
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: DIU150
• Device Catalogue Number: DIU150U195
• 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: 12/03/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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 Sex: Female