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	10/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: weight: unknown, information was requested but not provided.Section h3: the device was not returned for evaluation; 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.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
It was reported that after the preloaded multifocal intraocular lens (iol) was fully implanted in the patient¿s left eye, a refractive error was identified at a post-operative examination.The lens was subsequently explanted during a secondary surgery.There was no impact on the patient¿s daily activities.No unplanned incision enlargement, sutures, vitrectomy, or procedural delays occurred, and no additional medical treatment or medications beyond standard of care were required.The patient experienced temporary symptoms but retained a best spectacle corrected visual acuity (bscva) of 20/20 both pre-operatively and post-operatively.Directions for use were followed.No further information was provided.
Additional Manufacturer Narrative
Additional information: the following fields were updated accordingly based on the additional information received: section a2: age: 46 years.Section b5: additional information indicated that the replacement lens was the same model but with a higher diopter (drn00v +23.0d).The patient¿s evaluation was as follows: pre-op refraction: plano sphere; target: +0.16; post-op: +1.00 -0.25 × 16.It was confirmed that the patient had no pre-existing conditions that could have contributed to the reported issue.The account suggested that the device may have caused or contributed to the event.No patient injury was reported.The patient¿s outcome status reported as -0.50 sphere, with symptoms improved but still present.Section d9: device available for evaluation: yes, section d9: returned to manufacturer on: jan 6, 2026, section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection revealed that the lens was cut in half.The lens was cleaned and inspected; no further issues were identified.During the product evaluation it was confirmed that the physical characteristics of the lens matched a drn00v model lens.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The ¿lens cut¿ observed during product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Corrected data: upon review, it was identified that an incorrect date ((b)(6), 2025) was inadvertently entered in section ¿d6b¿ of the initial mdr report.This information has been corrected in this supplemental mdr, and the following field has been updated accordingly: section d6b: if explanted; give date: (b)(6) 2025.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: 23791332
• Report Number: 3012236936-2025-000332
• Device Sequence Number: 20226618
• Product Code: MFK
• UDI-Device Identifier: 05050474810792
• UDI-Public: (01)05050474810792(17)271122
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: 2025
• 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): 02/25/2026

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: DRN00V0215
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White