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 Impairment (2138); Visual Disturbances (2140)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 implanted in the left eye, the patient reported experiencing excessive glare and blurred vision, despite the lens being well-centered and no other issues with the eye.The issue was first noted during a post-operative visit.The patient was scheduled to undergo an iol exchange procedure.Through follow up, it was confirmed that the explant was successfully completed.Another johnson and johnson iol was implanted as replacement; ar40e model with a diopter of 21.5.The exchange procedure included a planned vitrectomy, but no sutures or additional medications outside the standard of care were required.There was no patient injury, and visual acuity and symptoms improved post-exchange.The post-operative refraction following the exchange was -0.50+0.50x113.The pre-operative refraction was +2.75+0.25x005, and the pre-operative best spectacle corrected visual acuity (bscva) was 20/30-.Post-operative refraction with the originally implanted lens was +0.50 sphere, and the post-operative bscva was 20/50, with an intended target refraction of plano sphere.The patient was not over or under corrected, and did not have any pre-existing conditions that affected the calculation.The patient had a loss of two lines of bscva.It was reported that the device caused or contributed to the event.No further information was provided.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information: section h3: device evaluated by manufacturer: yes device evaluation: visual inspection under magnification was performed on the suspect product and found the lens had a detached haptic and was coated in viscoelastic residue.The lens was cleaned and inspected, and no issues that could contribute to the complaint issues reported were observed.No further evaluation was performed.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The "detached haptic¿ observed during the product evaluation could not be confirmed to be related to the manufacturing or design process.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no similar complaint for this po number has been received.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.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: 24126764
• Report Number: 3012236936-2026-000021
• Device Sequence Number: 21431169
• Product Code: MFK
• UDI-Device Identifier: 05050474810822
• UDI-Public: (01)05050474810822(17)270515
• 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: 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): 02/03/2026

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: DRN00V0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White