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

Model Number	DIU225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Unspecified Eye / Vision Problem (4471)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was explanted from the patient's left eye after two months of implantation.The patient reported intolerable dysphotopsia and loss of best corrected vision.It was stated that the symptoms started as of day one post op, blurred vision, ghosting, blue tint, vibrating eye, headaches and his side vision had an irritating sharp light.These symptoms did not improve at 1 week or at future appointments.Lens was replaced with the same model and same diopter lens in a secondary procedure.There was no calculation issue.There was no patient injury.There was no medical/surgical intervention required.Patient's daily activities are not affected.The patient is doing good.No other information is available.
Additional Manufacturer Narrative
Section:a4 and a5: unknown/ asked but not available.Section b3: date of event: unknown, not provided, section h3: other 81: the device was not returned for evaluation.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 will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was noted that in the initial report submitted, "hm: other- intervention required, injury" should not have been indicated in section h6.As well as "company representative" should also not have been chosen as report source is section g2.Additional information: date of event (nov.30, 2023) and information on pre-op best corrected visual acuity, 20/30-1, post-op (post-initial implant) best corrected visual acuity, 20/20, (post-replacement implant) best corrected visual acuity, 20/20, intended/targeted post-operative refraction (for initial implant): plano, were provided but also inadvertently not indicated in the initial report submitted.This supplemental mdr is submitted to correct these.Field below updated: section b3: date of event: nov.30, 2023.Device evaluation: product evaluation was not performed because the product has not been received.The complaint issue reported could not be confirmed.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation the complaint issue reported could not be confirmed and no product deficiency or product malfunction could be 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: 19210371
• Report Number: 3012236936-2024-01229
• Device Sequence Number: 6961293
• Product Code: MJP
• UDI-Device Identifier: 05050474747159
• UDI-Public: (01)05050474747159(17)250921
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 06/07/2024

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: 09/21/2025
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U210
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2022
• 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: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male