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

Model Number	Z9002
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from a patient's left eye due to lens dislocation.The patient reported that their vision was never good after the cataract surgery.There was a capsule tear and the doctor¿s note indicated that he could see some very mild border distortion from what looked like the use of iris hooks.There was vitreous strand running to the cornea from the pupil at 11 o'clock.This was quite broad, and it was displacing the iol to the temporal side.The lens itself was decentered about 3 mm and he could see the edge of the optic in the pupil.Underneath the lens, there appeared to be a capsular bag with a rather small rhexis opening that was fibrosed.There was vitreous coming through the capsular bag to the anterior chamber.The doctor could see tension lines from vitreous traction.There were pars plana vitrectomy, optic capture of the iol and limbal relaxing incisions (lri) performed.There were no sutures required.A non-johnson & johnson lens, 18.5 diopter was used as a replacement iol.The patient outcome was reported to be excellent, and no injury was reported.No further information was provided.
Additional Manufacturer Narrative
The intraocular lens (iol) 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.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL IOL
• 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: 13564330
• Report Number: 3012236936-2022-00459
• Device Sequence Number: 5834486
• Product Code: HQL
• UDI-Device Identifier: 05050474530645
• UDI-Public: (01)05050474530645(17)240930
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: Z9002
• Device Catalogue Number: Z900200175
• 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: 01/24/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White