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

Model Number ZXT225

Device Problem Insufficient Information (3190)

Patient Problems Therapeutic Effects, Unexpected (2099); Blurred Vision (2137); Visual Impairment (2138)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

If explanted, give date: not applicable as the device remains implanted.(b)(6).The device was not returned for analysis (the lens remains implanted); therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) was implanted in a patient¿s left eye in inc 147 and positioned at 158.Calculation made by barrets toric and tecnis toric.Post-op visual acuity: 20/70, j5.It was reported that the patient is temporarily impaired.On (b)(6) 2020, the doctor reported that the patient is not satisfied with his visual quality and asked for an explant.The doctor repositioned the lens at axis, to 151 to see if the patient gets better, otherwise, the plan was to explant the lens.Additional the doctor reported that the eye before the surgery was +1,25 -1,50 110.After the surgery, patient chose flat.After repositioning, the patient also chose flat.However, the patient does not want the lens anymore.The doctor i indicated that he wants to exchange the lens for a toric monofocal, as he has implanted in the patient right eye (toric monofocal, zct 150 +19,50).It was noted that the doctor was planning to perform one more attempt of repositioning the lens.The iol implant had occurred on (b)(6) 2020, ten (10) days before the first notification was made.The doctor indicated that the patient was with a very poor vision, which did not get better with refraction.Normal pressure, normal fundus.The doctor had even made oct and angio, and alleged the lens was extremally well positioned, and that maybe the patient did something wrong.Vision 20/70, j5.On (b)(6) 2020, it was reported that an explant has not yet been performed.That the doctor scheduled additional medical examinations for the patient whom is to return the first week of (b)(6) 2021.No further information was provided.

Manufacturer Narrative

Additional information received on (b)(6) 2021, indicated that the surgeon had already repositioned the lens thrice.However, the patient was complaining on her close and far sight with visual acuity 20/60 j5.A toric monofocal lens was implanted in the right eye.And doctor will do the same for the left eye.From which, he will explant the symfony.Also, there was an 0.3 induced astigmatism.Additional information received on (b)(6) 2021, indicates that the lens was actually explanted from patient's left eye on (b)(6) 2021.Post-op day (b)(6), the doctor is waiting a bit more for neurological adaptation of the patient.The following sections were updated: section d6b: if explanted, give date? (b)(6) 2021; section h6: health effect: clinical code: induced astigmatism.All pertinent information available to johnson & johnson have been submitted.

• Brand Name: TECNIS SYMFONY TORIC
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11122159
• MDR Text Key: 225291227
• Report Number: 9614546-2021-07001
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474574601
• UDI-Public: (01)05050474574601(17)240520
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2024
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225I200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention