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

Model Number	DIB00
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Mechanical Jam (2983); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded johnson and johnson (jnj) intraocular lens (iol) was defective.The shooter could not be advanced.The technician advanced the lens for the doctor but noticed a lot of resistance.She informed the doctor of the resistance and then handed the device to the doctor.The doctor also felt resistance and felt uncomfortable using the device.The surgeon decided not to use the product.The product was stuck in the cartridge and did not have any patient contact.The technician pushed the iol thru in the sterile field.When they examined the iol under a microscope, they noticed a scratch.They cannot tell if the scratch was already there prior to advancing the lens.The procedure was completed with a backup lens of the same model and diopter.There were no complications such as a capsule tear, vitrectomy incision enlargement or sutures.The patient is doing well.No further information was provided.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6, patient information: declined to answer due to patient privacy concerns.Section b3, date of event: unknown, not provided.Section d6a, if implanted, give date: not applicable as the product did not contact the eye.Section d6b, if explanted, give date: not applicable as the product did not contact the eye, therefore not explantable.Section h3, device evaluated by manufacturer: 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 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.Attempts have been made to obtain the missing information.However, to date, it has not been received.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: 21701904
• Report Number: 3012236936-2025-000085
• Device Sequence Number: 7789572
• Product Code: HQL
• UDI-Device Identifier: 05050474731653
• UDI-Public: (01)05050474731653(17)270917
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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

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: DIB00U0150
• 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: 03/19/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• 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: Prefer Not To Disclose