MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number ZCT525

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Visual Impairment (2138); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/16/2022

Event Type  Injury  

Manufacturer Narrative

Weight and ethnicity: asku - asked but unavailable.If explanted, give date: not applicable, device remains implanted.Telephone number:(b)(6).Other: 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.(b)(4).Attempts have been made to obtain missing information; however, the account did not provide the information.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was initially reported that a patient implanted with a monofocal toric intraocular lens (iol) in both eyes was unhappy.Through follow-up we learned that the patient was not happy with their vision in the left eye.No issue was provided against the right eye.Account indicated that the patient's left eye had high astigmatism and posterior subcapsular cataract (psc).It was provided that the patient was not expecting to need readers post operatively as he expected having 20/20 vision post iol implantation.The left eye has residual astigmatism, but the lens is close to the expected axis, so no rotation was offered.Yttrium aluminum garnet (yag) capsulotomy was done to improve vision from posterior capsule opacification (pco).There was no further medical or surgical intervention required.Patient status is unknown; however, it was indicated that daily activities are not significantly affected; however, patient mentioned that it was hard to read.Patient does not want to undergo a lasik treatment to correct the refractive error.Visual acuity readings provided as 20/25 pre-operative and 20/30+2 post-operative.The iol remains implanted.No further information was provided.

• Brand Name: TECNIS IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14991037
• MDR Text Key: 295770172
• Report Number: 3012236936-2022-01689
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474589469
• UDI-Public: (01)05050474589469(17)240605
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZCT525
• Device Catalogue Number: ZCT5250195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• 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: 59 YR
• Patient Sex: Male