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 Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported preloaded toric intraocular lens (iol) was explanted from the patient's operative eye due to the patient not being happy.It is unknown if any additional medical or surgical intervention was required and replacement lens is unknown.The patient outcome is unknown.The device was discarded.No further information was provided.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6: unknown/not provided.Section b3: date of event: unknown/not provided.The best estimate date is between nov 19, 2025, and dec 5, 2025.Section d6b: if explanted, give date: unknown/not provided.Section h3: the device was not returned for evaluation as it was discarded; 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.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information was received from the sales representative reporting that the patient was unhappy and wants the lens removed, but does not want any other lens in the eye.The issue was possibly due to the biometry.Through follow-up with the surgical center, it was reported that the lens was implanted into the right eye.The patient's medical records show that the patient had no issues on the date of surgery or at any post-operative visit at the surgical center.There is no record of the lens being explanted.Through additional follow-up with the surgeon, it was learned that the patient has a refractive surprise, as the patient is more myoptic then originally hoped for due to a calculation issue; original measurements were not correct.The issue was noticed shortly after the lens was implanted.No intervention has been performed for this issue.The patient is deciding next steps, as the doctor reported being able to fix the issue once the left eye lens is implanted during cataract surgery, which has not yet occurred.The original right eye lens remains implanted at this time with no planned intervention.The original surgery for the right eye was routine with no complications or patient injury.No further information was provided.Corrected data: based on the additional information received, the lens remains implanted at this time and there is no indication that the lens was explanted as originally reported on the initial mdr.Therefore, this event is no longer considered reportable and the health effect - implact code of 4629 (device revision or replacement) and type of investigation code of 4115 (device discarded) that was originally reported on the initial mdr no longer applies.There will no longer be any further reporting under mfr report number 3012236936-2025-0003453, however, if additional information is received that changes the reportability decision a supplemental mdr will be 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: 23918855
• Report Number: 3012236936-2025-000345
• Device Sequence Number: 9082057
• Product Code: MJP
• UDI-Device Identifier: 05050474747098
• UDI-Public: (01)05050474747098(17)270807
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 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 Model Number: DIU225
• Device Catalogue Number: DIU225U180
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown