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	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: weight: unknown/not provided.Section a5: ethnicity: unknown/not provided.Section b3: date of event: unknown; requested but not provided.The best estimate date is between jun 12, 2025, and sep 29, 2025.Section d6b: if explanted; give date: not applicable, as the intraocular lens remains implanted.Section h3: device evaluation: the device was not returned to the manufacturing site as the lens remains implanted; therefore, product testing could not be performed, and the reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no similar complaints for this po number have been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Attempts were made to obtain the missing information; however, no additional information has been received.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 lenses (iol) were implanted in both eyes during cataract surgery, the patient was not happy with the lenses and experienced blurriness.The patient, who works as an electrician, reported difficulty seeing wires up close, which has affected daily activities.The patient was assessed as under-corrected with no loss of two or more lines of best spectacle corrected visual acuity (bscva).Pre-operative refraction was -2.00 -0.50 x 155 with a bscva of 20/20-2, while post-operative refraction was -0.25 d.S.With a bscva of 20/30.The intended target refraction was plano.A history of laser-assisted intrastromal keratomileusis (lasik) was noted as a pre-existing condition that influenced the lens calculation.There was no injury reported.The surgeon has decided to perform a lens exchange, though the procedure has not yet been scheduled.The lens remains implanted.No further information was provided.This report is to capture the left eye event.A separate report will be submitted to capture the right eye event.
Additional Manufacturer Narrative
Additional information: section b5 - describe event or problem: additional information received indicated that the patient had an explant on (b)(6) 2025.The replacement lens was dib00, 19.5 diopter.There were no additional interventions performed and no patient injury was reported.The patient outcome was reported as no issues.The lens was discarded due to being cut into pieces during the removal process.The following fields were updated based on the additional information received: section: d6b - if explanted: give date: (b)(6) 2025.Section h6 - health effect - impact code: 4629 (for device explanted).Section h6 - type of investigation: 4115 (for device discarded).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: 23372230
• Report Number: 3012236936-2025-000274
• Device Sequence Number: 13041283
• Product Code: MFK
• UDI-Device Identifier: 05050474810686
• UDI-Public: (01)05050474810686(17)270812
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/23/2025

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: DRN00V0160
• Was Device Available for Evaluation?: No
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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: Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Race: White