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

Model Number	DIU375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-2 patient age/date of birth: unknown as information was not provided.Patient requested no follow-up call.Section a-3a patient sex: unknown as information was not provided.Patient requested no follow-up call.Patient gender: unknown as information was not provided.Patient requested no follow-up call.Section a-4 patient weight: unknown as information was not provided.Patient requested no follow-up call.Section a-5 patient ethnicity: unknown as information was not provided.Patient requested no follow-up call.Date of event: unknown as information was not provided.The best estimation date is between (b)(6) 2024 (iol implant and complaint alert dates).Date explanted: not applicable as the iol remains implanted, therefore not explanted.Device evaluated by manufacturer: the device was not returned for evaluation as it remains implanted in the patient¿s ocular sinister (left eye).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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the diu375 model intraocular lens (iol) was implanted into the patient¿s ocular sinister (left eye).Patient stated that they are unable to view up close print or signs.Patient also see floaters, has blurred vision, and uses eye drops.Patient requested no follow-up calls.No further information is available.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that patient code hm-visual disturbance- dysphotopsia-transient was reported in error.Patients' reported visual issues were captured under the initial coding of blurry vision.Therefore, this supplemental filing is to correct the clinical code that were incorrectly reported.No further information is available.Section h6: health effect - clinical code: 2140 is no longer applicable 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: 19639927
• Report Number: 3012236936-2024-000180
• Device Sequence Number: 8610385
• Product Code: MJP
• UDI-Device Identifier: 05050474748231
• UDI-Public: (01)05050474748231(17)260714
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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: 07/14/2026
• Device Model Number: DIU375
• Device Catalogue Number: DIU375U160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2023
• 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: Required Intervention
• Patient Sex: Unknown