MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS SIMPLICITY; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DRN00V
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two single piece preloaded multifocal intraocular lenses (iol) tore during insertion into the patient¿s left eye.Both lenses were fully inserted and then cut in half in the eye and removed during the same procedure.This led to a delay in the procedure by approximately 15-20 minutes.No medication outside the standard of care was required.There was no unplanned incision enlargement, unplanned vitrectomy, or unplanned sutures.No patient injury was reported.Daily activities were not affected.The patient¿s status following the event is unknown.No further information was provided.This report is to capture the event for drn00v 11.5 diopter, serial number (b)(6).A separate report will be filed to capture the event for drn00v 11.5 diopter, serial number (b)(6).
Additional Manufacturer Narrative
Section a4: weight: unknown, information was requested but not provided.Section a6: race: unknown, information was requested but not provided.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same surgery.It is unclear which lens was removed and replaced and which lens was only removed, therefore, removal and replacement is being captured for both.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 was 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.
Additional Manufacturer Narrative
The product was received for evaluation.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: oct 29, 2025.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the suspect product and found the plunger rod fully advanced with viscoelastic residue observed throughout the cartridge.Stress marks were observed on the cartridge tip, and a bulge was observed on the cartridge tip.No issues were identified with the lens module, device assembly, and plunger rod advancement.The plunger rod tip was observed to be bent.The lens was received cut in half and coated in viscoelastic residue.The lens halves were cleaned revealing that the lens was damaged.No further evaluation was performed.The complaint issue was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.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: 23317862
• Report Number: 3012236936-2025-000266
• Device Sequence Number: 20117469
• Product Code: MFK
• UDI-Device Identifier: 05050474810594
• UDI-Public: (01)05050474810594(17)280224
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0115
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic