TECNIS SYMFONY TORIC ZXT300 ZXT300U180

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study,use report with the FDA on 2020-03-25 for TECNIS SYMFONY TORIC ZXT300 ZXT300U180 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[188490541] If explanted, give date: not applicable, as lens remains implanted. (b)(4). Device evaluation: product testing could not be performed because the product was not returned as lens remains implanted. The complaint cannot be confirmed. Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications. A search revealed that no similar complaints were received from this production order. Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10

[188490542] It was reported that clinical study patient underwent bilateral intraocular lens (iol) implants. At 1 month visit however, it was reported that the patient was very bothered by halos, very distractive in buildings; extremely bothered by starbursts, had safety concerns with driving; extremely bothered by multiple or double vision, totally disabling when it occurs; very bothered by glare, driving; moderately bothered by poor low light vision, nuisance. Preoperative visual acuity: best corrected distance visual acuity (bcva), right eye (od) 20/20; left eye (os) 20/20 the monocular uncorrected distance visual acuity (ucdva)? Od 20/25; os 20/25. Monocular bcdva? Od 20/15; os 20/15. On ocular exam posterior capsule opacification (pco)- both eyes, was noted. The subject is scheduled to have a yttrium aluminum garnet (yag) capsulotomy for the posterior capsule opacification (pco- laser treatment) in 1 week for the od and 3 weeks for the os. It was learnt that the subject had yag of od on (b)(6) 2020. Then on (b)(6) 2020 another yag for the os. The patient visual acuity is unknown at this time. No other intervention is planned. No further information available. This mdr report pertains to the right eye (od). A separate report will be submitted for the left eye (os).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9614546-2020-00149
• MDR Report Key: 9881582
• Report Source: HEALTH PROFESSIONAL,STUDY,USE
• Date Received: 2020-03-25
• Date of Report: 2020-03-25
• Date of Event: 2020-01-07
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-26
• Date Added to Maude: 2020-03-25
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: SOMYATA NAGPAL
• Manufacturer Street: 1700 EAST ST. ANDREW PLACE
• Manufacturer City: SANTA ANA CA 92705
• Manufacturer Country: US
• Manufacturer Postal: 92705
• Manufacturer Phone: 7142478200
• Manufacturer G1: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Manufacturer Street: VAN SWIETENLAAN 5
• Manufacturer City: GRONINGEN 9728NX
• Manufacturer Country: NL
• Manufacturer Postal Code: 9728 NX
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: TECNIS SYMFONY TORIC
• Generic Name: MULTIFOCAL IOLS
• Product Code: POE
• Date Received: 2020-03-25
• Model Number: ZXT300
• Catalog Number: ZXT300U180
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Manufacturer Address: 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-03-25
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-25