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

Model Number	DRN00V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section b3: date of event: unknown/not provided.The best estimate of the date of event is prior to jan 22, 2026.Section d6a: if implanted, give date: unknown/not provided; the extent of patient contact is unknown, however there is no indication that the lens was fully implanted.Section d6b: if explanted, give date: unknown/not provided; the extent of patient contact is unknown, however there is no indication that the lens was fully implanted, therefore, not explanted.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 during an implantation of a single piece preloaded multifocal intraocular lens (iol), the doctor noticed that it was cracked.The event was observed during the delivery.No further information was provided.
Additional Manufacturer Narrative
The product was received for evaluation.Device evaluation: visual inspection revealed that the cartridge tip was damaged.Ovd was observed inside the cartridge.The lens module, plunger rod, and handpiece were inspected, and no issues were observed.The lens was visually inspected revealing that the lens was damaged on the edge.No further issues were identified.The complaint issue "lens damaged" was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.The following fields were updated accordingly: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: feb 10, 2026.Section h3: device evaluated by manufacturer: yes.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: 24335244
• Report Number: 3012236936-2026-000041
• Device Sequence Number: 21279584
• Product Code: MFK
• UDI-Device Identifier: 05050474810730
• UDI-Public: (01)05050474810730(17)271217
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: DRN00V0185
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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
• Patient Sex: Unknown