MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DRN00V
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: 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.Section h3: the device was not returned for evaluation as it was discarded; 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.Section h6: health effect- impact code:4613-hm-anterior capsular rupture : anterior capsular rupture section h6: health effect- impact code 4631-pt-removal and replacement : procedural complications section h6: health effect- impact code 4625-pt-unplanned vitrectomy : surgical intervention section h6- health effect- impact code 4644- pt-medical intervention : interventional procedure section h6: health effect- clinical code 4581-hs-incision enlarged : procedural complications attempts has been made to obtain missing information; however, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during implantation of a preloaded multifocal intraocular lens (iol), model drn00v, into the patient¿s right eye, the haptics were stuck together, causing the lens to flip and resulting in a tear of the anterior capsule.The patient became very upset following the event.The surgeon subsequently cut the implant for removal and implanted the backup lens during the same procedure.An anterior vitrectomy was also required as part of the additional surgical maneuvers.The procedure was successfully completed using a non¿johnson & johnson replacement lens.Reportedly patient experienced huge anterior capsule tear.Additional interventions included an anterior vitrectomy, incision enlargement, and placement of a suture.Medication outside the standard of care (miochol) was administered.The current patient outcome is unknown, as the reporter has not spoken with the surgeon since the incident occurred.The complaint device was discarded.No additional information was provided.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 24284818
• Report Number: 3012236936-2026-000034
• Device Sequence Number: 20912517
• Product Code: MFK
• UDI-Device Identifier: 05050474810792
• UDI-Public: (01)05050474810792(17)280606
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0215
• 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: 01/13/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White