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

Model Number DIB00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

It was reported that the johnson and johnson (jnj) intraocular lens (iol) was explanted from the left eye.Reportedly, the patient¿s blurry vision may have been a miscalculation because the doctor had to change by two diopters.Doctor is not certain, but it seemed the iol was not positioned correctly, not sitting right in the eye.Customer said it could have been the patient¿s anatomy.The doctor is not saying the diopter is wrong, but he¿d like jnj to confirm it.The iol was replaced with another jnj model ar40e 23.0 diopter.The patient outcome is unknown.No further information was provided.

Manufacturer Narrative

Section a2, a4, a5 patient information: information unknown/not provided.Section b3, date of event: the exact date is unknown.The best estimate is between the implant and explant dates.(b)(6) 2023 and (b)(6) 2024, respectively.Section h3-other (81): the device has not been 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.Section h6- health effect ¿ clinical code: 4581 used to capture device decentered or dislocated or tilted subluxated or wrong position: device dislocation.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
• Type of Device: 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: 18843270
• MDR Text Key: 336957282
• Report Number: 3012236936-2024-00551
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731875
• UDI-Public: (01)05050474731875(17)250829
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female