TECNIS 1 MULTIFOCAL ZKB00 ZKB00I0240

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for TECNIS 1 MULTIFOCAL ZKB00 ZKB00I0240 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[188489545] Initial reporter phone: (b)(6). (b)(4). Device evaluation: the returned sample was evaluated. Visual inspection with the unaided eye revealed viscoelastic residue on the optic body and haptics, and that the lens was received cut in half, which is consistent with a lens that was handled during explant. Dimensional inspection was performed on both haptic widths and thickness, and the measurements were within specifications. Based on the return condition of the lens no further product evaluation (further visual inspection and additional dimensional inspection) could be performed. The complaint issue could not be confirmed, and no product deficiency was identified. Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported. The product was manufactured and released according to specifications. A search revealed that no other complaints have been received for this production order number. 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

[188489546] It was reported that during implantation of an intraocular lens (model zkb00 24. 0 diopter) in patient? S right eye (od) there was a stuck cartridge issue. They managed to finish up the surgery, but some marks on optic zone were noted when examined after the operation. The patient complained about discomfort of vision due to blur spot. Reportedly the lens was explanted in a secondary surgical procedure. Lens from another manufacturer was used as replacement for the patient. No further information provided. Visual acuity pre-operative: 0. 6, visual acuity post-operative: 0. 9. The patient had bilateral lenses implanted. This report will capture the lens implanted in the patient's right eye (od). A separate report will be filed for the left eye (os).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9614546-2020-00137
• MDR Report Key: 9864306
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-03-23
• Date of Report: 2020-03-23
• Date of Event: 2020-02-07
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-24
• Date Added to Maude: 2020-03-23
• 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 1 MULTIFOCAL
• Generic Name: MULTIFOCAL IOLS
• Product Code: MFK
• Date Received: 2020-03-23
• Returned To Mfg: 2020-03-12
• Model Number: ZKB00
• Catalog Number: ZKB00I0240
• 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: 2020-03-23
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-23