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

Model Number Z9002

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Blurred Vision (2137); Capsular Bag Tear (2639)

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date unknown/not provided.Best estimate date is between (b)(6) 2021 and (b)(6) 2023.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.Health effect - impact code: 4625 - additional surgery (suture & unplanned vitrectomy).Medical device problem code: 3191 - this code was used for (complication with the lens).Attempts were 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 indicated that an intraocular lens (iol) was explanted from a patient¿s right eye due to complication with the lens.A non-johnson and johnson sulcus lens of a different diopter (28.0 d) was used as the replacement.A vitrectomy was performed, and suture was used.It was indicated that the patient is healing well.Additionally, it was explained that at the time of cataract surgery in 2021, the patient did not have a good eye health to start with.That this was a complex cataract surgery which lysis of synechia was reported on (b)(6) 2021, there was discontinuous capsule and the patient had blurry vision.But the account was not sure if this information pertained to patient's issues prior to cataract surgery of after the lens was implanted.No further information was provided.

Manufacturer Narrative

Corrected data: in review, it was noticed that incorrect age (68) was inadvertently entered in the section "a2" of the initial mdr report.Therefore, the information has been added in this supplemental mdr report and the following field was updated accordingly: section a2: age: 71 years.Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: feb 13, 2023.Section h3: device evaluated by manufacturer: yes.Additional information received from customer indicated that a yttrium-aluminum-garnet (yag) laser was performed.The following field was updated accordingly to capture the additional information received: section h6: health effect - impact code: 4625 yag (yttrium aluminum garnet).Device evaluation: the complaint lens was received inside of a specimen cup.An additional label was received on the bag.Visual inspection under magnification revealed that the complaint lens was received cut in half.The lens was cleaned and lens damage consistent with yag laser treatment was identified on the lens.Based on the return condition of the lens no further product evaluation could be performed.Conclusion: the complaint issues were not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: in review, it was noticed that the following fields were inadvertently left blank in the section "d9" of the supplemental mdr report #1; therefore, the information has been corrected in this supplemental mdr report and the following fields were updated accordingly: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: feb 13, 2023.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL IOL
• 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: 16439982
• MDR Text Key: 310228620
• Report Number: 3012236936-2023-00412
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474530843
• UDI-Public: (01)05050474530843(17)211101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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: 71 YR
• Patient Sex: Female