TECNIS SYMFONY TORIC ZXT225 ZXT225U175

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-25 for TECNIS SYMFONY TORIC ZXT225 ZXT225U175 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[188490787] (b)(4). Device evaluation: the lens was received in a specimen cup in an unknown liquid at the manufacturing site for evaluation. Visual inspection with the unaided eye revealed that the lens was received cut in half, which is consistent with a lens that was handled during explant. Based on the return condition of the lens no product evaluation could be performed. The complaint issue could not be confirmed, and no product deficiency was identified. Manufacturing record review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specifications. A search in complaint system revealed that no similar complaints were received for this production order. Conclusion: as a result of the investigation there is no indication of a product quality deficiency. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10

[188490788] It was reported that at a 6-month clinical study visit, the subject was unhappy, complained of near visual acuity (va), blurred va in the left eye (os) and requested for the lens to be explanted. The intraocular lens (model zxt225 17. 5 diopter) was explanted from patient? S left eye in secondary surgical procedure. A replacement lens of the same model, but different diopter (18. 5) was used. There were no surgical interventions such as vitrectomy, incision enlargement or sutures required. The patient? S outcome at the time of discharge was reported to be good and there was no patient injury. Uncorrected distance visual acuity (ucdva) for the left eye (os): 20/30, best corrected distance visual acuity (bcdva) for os: 20/20. Preoperative visual acuity: uncorrected distance visual acuity (ucdva) for the left eye (os): 20/80, best corrected visual acuity (bcva) for os: 20/20. The 1-month visit was on (b)(6) 2019. Monocular ucdva? Od: 20/30; os: 20/30, monocular bcdva? Od: 20/25; os: 20/25. No further information was reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9614546-2020-00145
• MDR Report Key: 9878261
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-25
• Date of Report: 2020-03-24
• Date of Event: 2020-01-30
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-25
• 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
• Returned To Mfg: 2020-03-16
• Model Number: ZXT225
• Catalog Number: ZXT225U175
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• 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