MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number ZCT150

Device Problems Contamination (1120); Device Contaminated During Manufacture or Shipping (2969)

Patient Problems Inflammation (1932); Blurred Vision (2137); Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact date of event is unknown, not provided, but the best estimate date is (b)(6) 2021.If explanted, give date: not applicable as the lens remains implanted.The device was manufactured at the kulim site which has been closed.The device is not returning for evaluation as it remains implanted; 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, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a patient complained about their vision and the doctor found plastic pieces bilaterally on each intraocular lens (iol).The lenses have not been explanted but the doctor did attempt to remove the foreign body.A microorganism culture found nothing.The doctor saw the patient in (b)(6) 2021 with complaints of photophobia, decreased vision in both eyes which is the first record of anterior segment foreign body.Reportedly, this issue was not noted in post operative visits or retina visit at outside offices.Initial medical treatment with aggressive topical steroids and nsaids was successful, inflammation and vision both improved however both worsened after tapering of drops.The patient went through the cycle a few times without success of tapering off drops.Through three (3) weeks tapering drops, the vision remained 20/40 best corrected visual acuity (bcva).The appearance of foreign body was completely unchanged after several months.The doctor decided to go for surgery on (b)(6) 2021 for foreign body removal and it did not behave as expected.The doctor was unable to get enough to send for pathology but they cultured a fragment and the ac which were negative for infection.The doctor reported that the material was slimy and fixed firmly to the lens which he scraped it with a metallic sinsky hook but he was unsuccessful in removing it.The lens was not exchanged.No further information was provided.The patient had bilateral lens implants.This report is for the patient¿s right eye.A separate report will be submitted for the patient¿s left eye.

Manufacturer Narrative

Additional information: customer provided photographs and video for evaluation.The johnson & johnson subject matter expert (sme) evaluated the provided photographs/video and an artifact of approximately 1mm in length was observed in the center of the pupil along with background haziness and whitening of the remnant of the anterior capsule.The customer provided video was evaluated but the source, nature, and potential clinical impact could not be determined.Corrected data: in review, it was noted that the code "2969" was inadvertently entered in the section "h6 - medical device problem code" of the initial mdr report instead of "1120" which is incorrect.Also, it was noted that the medical device problem code (1932) for inflammation was inadvertently not entered in section 'h6' of the initial mdr report.In addtion to that, it was indicated that the patient has inflammation of both eyes, left worse than right, which the doctor feels may be due to what ever the debris is on the anterior aspect of the lens.Therefore, the information has been corrected and captured in this supplemental mdr report and the following field was updated accordingly: section h6: medical device problem code: 1932.Section h6: medical device problem code: 1120.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: in review, it was noted that the patient's age, date of birth and gender were inadvertently not entered in the initial or supplemental mdr#1 reports; therefore, the information has been captured in this supplemental mdr report and the following fields were updated accordingly: section a2: age / date of birth: 58 years / (b)(6) 1963.Section a3: gender: female.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 12844662
• MDR Text Key: 281028333
• Report Number: 3012236936-2021-00044
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474552029
• UDI-Public: (01)05050474552029(17)210827
• 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,Followup,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2021
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2017
• 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 Age: 58 YR
• Patient Sex: Female