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

Model Number	DIU525
Medical Device Problem Codes	Application Program Problem: Dose Calculation Error (1189); Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown/ asked but not available.Section b3:unknown/ asked but not available.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.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) was explanted from the patient's right eye.Explant was due to an unknown reason.The suspect iol was replaced with another same-model but low-diopter johnson and johnson iol.Patient status is unknown.No other information was provided.
Additional Manufacturer Narrative
Additional information: additional information received on 02/20/2023 and revealed that the initial ora verification resulted in incorrect power.Needed lens with stronger astigmatism power.Iol reposition done on (b)(6) 2023.Patient satisfied with results and no injury.Based on additional information the following sections have been updated accordingly: based on the additional information received, the codes from the initial mdr of code 1845 - eye injury, 2993 - adverse event without identified device or use problem and are no longer applicable.The following codes have been added to reflect the new information: section h6: health effect - impact code: code 4628 - device repositioning.Section h6: health effect - clinical code: code 4582 -no clinical signs, symptoms or conditions.Section h6: medical device problem code: code 1667 - unstable.Section h6: medical device problem code: code 1189 - application program problem: dose calculation error.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: 18625990
• Report Number: 3012236936-2024-00147
• Device Sequence Number: 12745412
• Product Code: MJP
• UDI-Device Identifier: 05050474749610
• UDI-Public: (01)05050474749610(17)260419
• 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: 2023
• Device Explanted Year: 2023
• 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): 03/15/2024

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 Expiration Date: 04/19/2026
• Device Model Number: DIU525
• Device Catalogue Number: DIU525U260
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• 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 Age: 57 YR
• Patient Sex: Female