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	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
The pre-loaded diu300 model intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye).Patient reports his blurry vision for distance without glasses significantly interferes with his daily activities, he is visually fastidious, and is very unhappy with distance vision.There was no patient injury, no medical intervention, and no surgical intervention during the initial procedure.Pre-operative uncorrected best corrected visual acuity (bcva) was reported as 20/30 and glare 20/50 and post-operative uncorrected visual acuity (ucva) was 20/70 and bcva was 20/25+2.An iol explant procedure is scheduled for (b)(6) 2025 however, there is no confirmation that the iol explant has occurred.No further information is available.
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: unknown/asked information was not provided.Section a-4 patient weight: unknown/asked information was not provided.Section b-3: date of event: unknown as information was not provided.The best estimation date is between (b)(6) 2024 and 09-jan-2025 (iol implant and complaint alert dates).Section d-6b date explanted: not applicable as the iol remains implanted; therefore, not explanted.Section h-3 device evaluated by manufacturer: the complaint device was not returned for evaluation as it remains implanted.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 08-apr-2025.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the lens was received in a specimen cup with a piece of foam.During a visual inspection, the device was inspected under magnification.The lens was visually inspected under magnification revealing that the lens was cut in half.The lens was cleaned and inspected, and light scratches were observed on the surface of the lens.No issues that could cause or contribute to the complaint issues were observed.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The ¿cosmetic issues" observed during the product evaluation could not be confirmed to be related to the manufacturing or design process.The manufacturing records for the product were reviewed, the units were released in accordance with specifications.A search revealed that no other complaints have been 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 was identified.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: 21330570
• Report Number: 3012236936-2025-000033
• Device Sequence Number: 12882966
• Product Code: MJP
• UDI-Device Identifier: 05050474747753
• UDI-Public: (01)05050474747753(17)251007
• 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
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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 Expiration Date: 10/07/2025
• Device Model Number: DIU300
• Device Catalogue Number: DIU300U215
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 06/08/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White