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

Model Number	DIB00
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a3b, a4 and a5: unknown/ asked but not available.B5 - date of event, unknown/not provided.Section d6a: if implanted, give date: unknown, information not provided.Section d6b: if explanted, give date: not applicable, remains implanted in the eye.Section h3: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that trailing haptic of the preloaded intraocular lens (iol) was getting stuck on the injector and was able to be released with a forceps to rip the haptic out of the injector leaving the haptic outside of the eye.From additional information it was learnt that during implantation of the lens the trailing haptic of the lens had stuck in the preloaded cartridge.The surgeon had to pull the lens out with a forceps and implant the lens.So the cartridge and the shooter had touched the patient's eye.The lens is still implanted in the patient's eye as there was nothing wrong with it.The patient is doing well.No other information is available.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: june 17, 2025.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the suspect product and found the plunger rod was fully advanced.No damage to the cartridge was observed.Ovd was observed inside the cartridge.The lens module, plunger rod, and handpiece were inspected, and no issues were observed.No lens was received for evaluation.No further evaluation was performed.The complaint issue "delivery issue" could not be confirmed during product evaluation, and no issues were identified.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: 21335086
• Report Number: 3012236936-2025-000034
• Device Sequence Number: 12869713
• Product Code: HQL
• UDI-Device Identifier: 05050474731912
• UDI-Public: (01)05050474731912(17)270517
• 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): 08/15/2025

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: DIB00U0275
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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