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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced blurry vision and difficulty focusing on distant objects and printed materials following implantation of a preloaded multifocal intraocular lens (iol), model dfr00v, in the right eye.Vision was initially good after surgery; however, approximately two years ago, the patient began experiencing intermittent episodes of blurry vision.The physician diagnosed dry eye and prescribed lubricating eye drops, which provided temporary improvement.Although the dry eye symptoms later resolved, the patient continues to experience persistent blurry vision rather than occasional episodes.A yag laser treatment was performed one month ago, but the problem remain.According to the patient, vision sometimes becomes very blurry and problematic, while at other times it is clear enough to tolerate.The complaint device remains implanted.No additional information was provided.
Additional Manufacturer Narrative
Section b3: date of event: unknown, not provided, but the best estimate date is on or after to (b)(6) 2021.Section d6a: implant date: (b)(6) 2021.Section d6b: if explanted; give date: n/a (not applicable).The intraocular lens remains implanted.Section h3: the device was not returned for evaluation as it remains implanted; 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.Section h6: health effect- impact code: 4619-hm-blurry vision (impacting daily life activities) : vision blurred (impacting patient daily life activities).Section h6: health effect- impact code:4613- hm-dry eye : dry eye.Section h6: health effect- impact code 4625- pt-secondary surgical intervention : surgical intervention.Section h6: health effect-impact code 4644- pt-medical intervention : interventional procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind.; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 24223038
• Report Number: 3012236936-2026-000030
• Device Sequence Number: 8197023
• Product Code: MFK
• UDI-Device Identifier: 05050474750630
• UDI-Public: (01)05050474750630(17)240522
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

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: 05/22/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU180
• 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: 01/05/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2021
• 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 Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American