MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS SIMPLICITY; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DRN00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the preloaded johnson and johnson (jnj) intraocular lens (iol) was implanted into the patient¿s left eye.The customer reported a refractive surprise as the patient came more myopic than expected.The iol was chosen per post myopic lasik calculations.However, the patient ended up with -1.75d myopia unexpectedly.The calculations were re-done with both ascrs (american society of cataract and refractive surgery) and the barrett true k calculators.The doctor reimaged iolm ((intelligent optical link mapper) ) and topography, had two other surgeons review paperwork, topography, calculations etc¿ and it is unclear where the error has been made.The implanted lens is also correct.The doctor discussed the issue with the patient at length.Additionally, the patient has experienced difficulty with work and driving due to the refractive outcome.As a result, the patient and physician planned to explant the iol and replace it with another johnson and johnson iol model odyssey +24.5d diopter mfiol (multifocal intraocular lens).The iol was subsequently explanted, however, the exact replacement iol information was not provided.During the procedure there were no complications such as a capsule tear, vitrectomy, or sutures.And no medication outside the standard of care.The patient outcome is being monitored and is reported as pending.No further information was provided.
Additional Manufacturer Narrative
Section a4, patient weight: unknown/not provided.Section a5, ethnicity: unknown/not provided.Section a6, race: unknown/not provided.Section h3, device evaluated by manufacturer: the device has not been returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record 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 have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information section d9: device available for evaluation? yes section d9: date returned to manufacturer: feb 10, 2026 section h3: evaluated by manufacturer? yes device evaluation: the complaint lens was received.The lens was visually inspected revealing that the lens was cut and coated in viscoelastic residue and blood.The lens was cleaned and inspected, and no further issues were identified.During the product evaluation it was confirmed that the physical characteristics of the lens matched a drn00v model lens.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 24196605
• Report Number: 3012236936-2026-000026
• Device Sequence Number: 10149690
• Product Code: MFK
• UDI-Device Identifier: 05050474810884
• UDI-Public: (01)05050474810884(17)270408
• 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: 2025
• Device Explanted Year: 2026
• 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): 02/27/2026

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: DRN00V
• Device Catalogue Number: DRN00V0260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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 Age: 58 YR
• Patient Sex: Female