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 Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the preloaded toric intraocular lens (iol) is planned for an iol exchange to a monofocal lens as the patient is bothered by halo and glare at night.The patient has 20/20 vision and j1 near acuity in both eyes.The patient cannot perform prior to surgery like driving at night has affected the daily activity.Preoperative best corrected visual acuity (bscva) was 20/30 and 20/20 , postoperatively.No unplanned incision enlargement, vitrectomy, or sutures required.The patient is temporarily impaired.The lens is not available for return as it remains implanted.Additional information received on march 31, 2026, confirmed that explant was performed from the right eye (od).The replacement lens is a non¿johnson and johnson lens.The patient is unable to exercise and is unsure if this is due to the iol or another cause.The patient is neither overcorrected nor under corrected and did not lose two or more lines of bscva (best spectacle corrected visual acuity).The preoperative refraction was +1.00 +0.50 × 144 with a bscva of 20/25.The postoperative refraction was plano sphere with a bscva of 20/20.The intended target refraction was plano, and the postop refraction after lens exchange was 20/30 uncorrected.A suture was required to secure the main incision after iol explant.The patient was prescribed multiple dry eye treatments, including restasis, vevye, and meibo.The patient is doing okay two days after the lens exchange.No further information provided.This report is to capture the event for the od.There is a separate report to capture the event for the os.
Additional Manufacturer Narrative
Section a4: weight: unknown/ 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.Attempts have been made to obtain missing information; however, to date, the information has not been provided.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: april 28, 2026 section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint device reveal that the lens was cut in half and coated in viscoelastic residue.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.The complaint issues were not identified during product evaluation.The observed issues during the 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: in review, it was noticed that the following information was inadvertently not included in the initial mdr report; therefore, it has been included in this supplemental mdr report as indicated below: section b5: the patient stated, he would get more tired since initial surgery.No further intervention is planned.Section h6: health effect - impact code: 4619 - temporary impairment (this code is used for the reported glare surgical intervention required, halo vision- surgical intervention required & blurry vision).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: 24968731
• Report Number: 3012236936-2026-000084
• Device Sequence Number: 14665110
• Product Code: MFK
• UDI-Device Identifier: 05050474810846
• UDI-Public: (01)05050474810846(17)280324
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: DRN00V0240
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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: 68 YR
• Patient Sex: Male
• Patient Race: White