TECNIS SYMFONY ZXR00 ZXR00U0185

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-12 for TECNIS SYMFONY ZXR00 ZXR00U0185 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[188486578] Additional information: date of event: unknown as information was not provided. The best estimate date is between (b)(6) 2018 and (b)(6) 2019. (b)(4). Device evaluation: the lens was received stuck to foam in a small box, and a completed complaint product shipping guide was also received. Visual inspection under magnification revealed that the lens was received almost cut in half (but not separated), which is consistent with a lens that was handled during explant. Additionally, viscoelastic residue was observed on the optic body and haptics. Particles were observed on the lens, which can be attributed to receiving the lens stuck to foam. Based on the condition of the return lens no further product evaluation could be performed. No complaint issue could not be confirmed, and no product deficiency was identified. Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification. Historical data analysis: a search revealed that no other complaints for this production order number have been received. Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency. The reported issue was not verified. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10

[188486579] It was reported zxr00 18. 5 intraocular lenses (iol) was implanted in the patient? S left eye on (b)(6) 2018 and reported complaints of glare. Through follow up, additional information was received stating zxr00 18. 5 diopter lens was explanted (b)(6) 2019 due to additional complaints of hyperopic astigmatic outcome, positive dysphotopsia, very poor night vision due to glare - unable to drive at night, and replaced with a non-johnson & johnson surgical vision lens. There was no incision enlargement and no patient injury. Vitrectomy (pars plana vitrectomy - ppv) and limbal relaxing incision(s) (lri) were performed. Patient outcome reported as: patient happy and feels that symptoms have resolved. No additional information was provided to johnson & johnson surgical vision.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9614546-2020-00121
• MDR Report Key: 9827553
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2020-03-12
• Date of Report: 2020-03-12
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-13
• Date Added to Maude: 2020-03-12
• 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
• Generic Name: MULTIFOCAL IOLS
• Product Code: POE
• Date Received: 2020-03-12
• Returned To Mfg: 2020-03-05
• Model Number: ZXR00
• Catalog Number: ZXR00U0185
• 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: 2020-03-12
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-12