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	Halo (2227); Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported regarding the johnson (jnj) intraocular lens (iol).The patient¿s husband called to report that his wife has a johnson and johnson iol implanted in both eyes.This report is for the left eye.During the initial phone call his wife (the patient) joined the conversation.During a follow-up phone call only, the husband spoke about the issues experienced by his wife.The following summary of the event combines information from both conversations.After the iols were implanted the patient reported having issues.The patient sees clearly during the day.Her distance vision is ¿wonderful¿.The main complaint is halos at night that interfere with their depth perception to the point where she cannot drive at night.The patient only drives during the day due to the halos.The patient anticipated a full range of vision without glasses.However, the patient needs prescription glasses and a magnifying glass to read.She cannot read more than 5 minutes at a time, and this has persisted since her implants.The doctor said her vision is 20/20.The husband believes that because the iol is designed for full range vision, his wife should not require prescription glasses for reading.Reportedly, the vision in her left eye is better.The husband believes that something went wrong with her right eye.He heard the doctor say there was a fold or flap in the capsule or in the iris during the procedure.However, the husband also said that the doctor did not specify where the fold was located.He also stated that a week after the procedure in her right eye, medicine was applied and a cup was put over the eye for a week.No cup or medication was used on her left eye.Since the patient¿s physician retired, they sought a second opinion 6 months ago.(six months from the date they contacted jnj).The second opinion doctor mentioned that there is a film/secondary cataract in her right eye behind the lens and recommended a yag procedure to clear the ¿film¿.The doctor indicated it may not correct the issue.The patient chose not to undergo the yag procedure due to concerns that the intraocular lens (iol) could not be explanted after the procedure.It was mentioned that the patient has not had lasik surgery and does not have astigmatism.No further information was provided.Note.Right eye manufacturer report number 3012236936-2026-0001609.
Additional Manufacturer Narrative
Section a2, a4, a5, a6, patient information: unknown/not provided.Section b3, date of event: it was reported ¿soon after the implant¿.Section d6b, if explanted, give date: not applicable as the device remains implanted.Section h3, device evaluated by manufacturer: the device was not returned for evaluation as it remains implanted.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempt was 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.

• 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: 25364280
• Report Number: 3012236936-2026-000160
• Device Sequence Number: 18823795
• Product Code: MFK
• UDI-Device Identifier: 05050474810853
• UDI-Public: (01)05050474810853(17)260916
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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 Expiration Date: 09/16/2026
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0245
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2023
• 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: Other
• Patient Sex: Female