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

Model Number	DIB00
Medical Device Problem Codes	Break (1069); Device Difficult to Setup or Prepare (1487); Mechanical Jam (2983); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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 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 surgery, a preloaded monofocal intraocular lens (iol), model dib00, appeared to be defective.When the surgeon attempted to implant the lens into the patient¿s right eye, the lens did not deploy properly.It only partially released, resistance was noted during delivery, and the lens bent and became stuck to the delivery device.As a result, the lens was not implanted.The surgeon removed the device with the lens still attached.Although the device and lens contacted the patient¿s eye, no harm was observed.The defective device was removed from the surgical field, and a new lens of the same model and diopter was successfully implanted.No incision enlargement, vitrectomy, sutures, or other additional interventions were required.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: february 10, 2026.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.The cartridge tip and cartridge were damaged.No issues were observed with the lens module, device assembly, plunger rod, and plunger rod advancement.The lens was coated in viscoelastic residue, cleaned and the lens was observed to be damaged and scratched; a small tear was observed on the edge of the lens.A haptic was detached and damage to the haptics were observed.No further evaluation was performed.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 complaint issues "difficult to use", "delivery issue" and "stuck in cartridge" were not identified during photo and product evaluation.Conclusion: based on the complaint investigation results, 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: INTRAOCULAR LENS
• 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: 24299604
• Report Number: 3012236936-2026-000037
• Device Sequence Number: 10165921
• Product Code: HQL
• UDI-Device Identifier: 05050474731844
• UDI-Public: (01)05050474731844(17)270124
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: DIB00
• Device Catalogue Number: DIB00U0240
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American