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

Model Number	DIU225
Medical Device Problem Codes	Difficult to Insert (1316); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Macular Edema (1822); Capsular Bag Tear (2639)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: unknown/ asked but not available.Section b3: date of event: exact date is unknown/not provided.Best estimate date is on or prior to sep 30, 2024.Section d6a: implant date: unknown, information not provided.Section d6b: if explanted, give date: not applicable as the device remains implanted.Section h3(no): the intraocular lens (iol) is not returning for evaluation as the lens 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 will be filed.An attempt has been made to obtain missing information; however, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The surgery center reported lens malfunction during insertion of a monofocal toric intraocular lens (iol) into a patient's right eye.That haptics stuck together on the preloaded iol.The lens was able to be manipulated to where haptics opened, but the haptics popped open an caused a capsular tear.The doctor was not able to rotate the lens into position without causing it to fall to back of the eye.A vitrectomy was performed and the patient is stable (it is not 20/30 uncorrected post-op, day-3).Patient to be corrected with glasses.Retina exam done and eye looks good.The viscoelastic product used at room temperature, immediately after preparing.The issue did not significantly interfere with daily activities.No other surgical or medical interventions required or are planned and they are still observing the patient.The patient's outcome status was indicated to having issues.No further information was provided.
Additional Manufacturer Narrative
Additional information: additional information provided by the doctor indicated that he had the patient come back for multiple visits in order to see just how the patient has faired.The affected eye was reported to be the right eye.The patient is more than 1-month out from surgery and on (b)(6) 2024, her visual acuity was reported to be 20/40 best corrected.Present time outcome is that the patient has cystoid macular edema that is worsened likely due to her complex surgery which is more likely whenever there is vitreous prolapse during surgery.She will be seeing retina and may need injections to help with the edema.The patient's vision post op day-3 uncorrected was 20/30, now it is 20/40 best correct due to cystoid macular edema.The lens remains implanted and is stable.It was noted that the patient did not have any pre-existing issues that could have lead to the capsular tear.The following fields were updated accordingly based on the additional information received: section a4: weight: not available (n/a), but only mildly obese.Section b3: date of event: 9/26/2024.Section d6a: implant date: on (b)(6) 2024.Additional code added: section h6: health effect - clinical code: 1822 - macular edema.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: 20534927
• Report Number: 3012236936-2024-000288
• Device Sequence Number: 17817021
• Product Code: MJP
• UDI-Device Identifier: 05050474747166
• UDI-Public: (01)05050474747166(17)270522
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U215
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White