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

Model Number	DIU300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: female.Section d-6b date explanted: not applicable as the iol remains implanted; therefore, not explanted.Device evaluation: product evaluation was not performed because the product has not been received.If product is received after initial closure, the pi and cp (if necessary) may be re-opened to complete the return investigation.The complaint issue reported could not be confirmed.The manufacturing records for the product were reviewed, the units were released in accordance with specifications.The search revealed that no other complaints were received for this production order (po) number.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded johnson and johnson (jnj) intraocular lens (iol) was implanted into the patient¿s left eye.Post-operative complications were noted, including hyperopia at the one-week post-operative mark (on (b)(6) 2025), with an uncorrected visual acuity of 20/40+1 and reports of blurry vision.Manifest refraction was measured at plano+1.00x106, achieving a corrected visual acuity of 20/20, though it was not deemed satisfactory.Testing with a +2.0 d cylinder trial lens at 107 degrees produced an over-refraction of -1.00+0.75x174, resulting in a visual acuity of 20/20-, with a slow and unclear endpoint.The intended axis for the toric lens was 21 degrees, but the achieved axis was slightly misaligned at 17 degrees.Despite accurate pre-operative measurements and calculations, the patient experienced significant post-operative refractive error, necessitating consideration of a different model and diopter, such as diu150.The patient, who was previously able to drive, reported an inability to drive at night due to issues with vision clarity, which has been described as debilitating.The intraocular lens remains implanted, with the explantation planned but not yet performed.The surgeon was connected to the jnj medical affairs team for support.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: 22152218
• Report Number: 3012236936-2025-000152
• Device Sequence Number: 8394053
• Product Code: MJP
• UDI-Device Identifier: 05050474747623
• UDI-Public: (01)05050474747623(17)271121
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DIU300
• Device Catalogue Number: DIU300U150
• 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: 05/15/2025
• Initial Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White