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

Model Number	DIB00
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: section a-4 patient weight: unknown/asked information was not provided.Section a-5 patient ethnicity: unknown/asked information was not provided.Section a-6 patient race: unknown/asked information was not provided.Section d-6a date implanted: not applicable as the iol was not implanted.Section d-6b date explanted: not applicable as the iol was not implanted; therefore, not explanted.Section h-3 device evaluated by manufacturer: the complaint 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 report will be filed.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
After implanting the dib00 model intraocular lens (iol) in the patient¿s ocular dexter (right eye), the surgeon reported the trailing haptic was missing.When removing the iol, the doctor had issues cutting the lens and the incision was enlarged.There was a procedural delay of twenty (20) minutes; however, there was no sutures and no vitrectomy.Patient status post procedure was reported as temporarily impaired.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 13-nov-2025.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the simplicity that corresponds to this compliant was received inside the original folding carton.The patient stickers, implant notification card, and a lens taped to a piece of paper were received.During a visual inspection, the device was inspected under magnification.The compliant simplicity was visually inspected under magnification revealing 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 identified.The lens was removed from the tape it was received on, cleaned, and inspected, and was observed to be torn with 2 detached haptics, one haptic was missing.The lens was also observed to be damaged.The manufacturing records for the product were reviewed; the units were released in accordance with specifications.A search revealed that no other complaints have been received for this production order (po) number.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: 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: 23398250
• Report Number: 3012236936-2025-000279
• Device Sequence Number: 10015367
• Product Code: HQL
• UDI-Device Identifier: 05050474731721
• UDI-Public: (01)05050474731721(17)280717
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2025

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: DIB00
• Device Catalogue Number: DIB00U0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2025
• 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 Sex: Male