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

Model Number	DRN00V
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during implantation of a preloaded multifocal intraocular lens (iol), resistance was encountered and the lens became stuck within the cartridge.The lens was not implanted, and a backup lens of the same model and diopter was used to complete the procedure.Unplanned sutures were required; however, it was indicated that sutures are not part of the physician¿s standard practice, and the reason for their use is unknown.The cartridge tip contacted the patient¿s right eye.No surgical delay, unplanned vitrectomy, or incision enlargement was reported.No patient injury (e.G., capsule tear) occurred, and the degree of resistance was not specified.Trypan blue was used on an as-needed basis and is not considered outside the standard of care.The patient fully recovered with no reported impact on daily activities.Directions for use were followed.Product return status is unknown and the lens was likely discarded post-procedure.Device preparation included filling the cartridge with balanced salt solution (bss) via the hydration port, and the lens was initially advanced by a surgical technician.Additional details, including the number of twists, timing prior to handpiece delivery, and storage duration, are unknown.No further information was provided.
Additional Manufacturer Narrative
Section a6: race: unknown, information was requested but not provided.Section d6a: if implanted, give date: not applicable, the lens was not implanted.Section d6b: if explanted, give date: not applicable, the lens was not implanted.Hence, not explanted.Device evaluation: the original folding carton was received inside a plastic bag.The patient sticker, implant notification card, and patient implant identification card was also received.No other product was received.Product evaluation was not performed because the complaint product has not been received.The complaint issue reported could not be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no other complaints were received for this po.Conclusion: based on the investigation, no malfunction or product deficiency was 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: 25029750
• Report Number: 3012236936-2026-000115
• Device Sequence Number: 10260697
• Product Code: MFK
• UDI-Device Identifier: 05050474810709
• UDI-Public: (01)05050474810709(17)271212
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: DRN00V0170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• 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: 04/07/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• 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
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic