TECNIS 1 MULTIFOCAL ZLB00 ZLB00U0160

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 2020-03-19 for TECNIS 1 MULTIFOCAL ZLB00 ZLB00U0160 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[184059108] Additional information: patient age/date of birth: unknown as information was not provided. If explanted; give date: not applicable as the iol remains implanted in the patient? S ocular dexter (right eye). Device evaluation: product testing could not be performed because the product was not returned. The reported issue was not verified. Attached picture was reviewed and observed what is alleged as a strand in the posterior surface of the lens (foreign matter), which locations seems to be peripherical (visual axis off), although the material appears to be acrylic, it can not be confirmed from a picture assessment. A product quality deficiency could not be confirmed. 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

[184059109] After zlb00 16. 0 diopter intraocular lens (iol) was implanted in the patient? S ocular dexter (right eye) the surgeon reported there was an acrylic strand originating on the posterior surface of the implant in the periphery. Broadest at origin ending in a wisp probably 3 mm total length and firmly attached. The strand is definitely not from cartridge, it is integral to the lens. Surgeon used two instruments but could not separate the strand from optic as it was part of same acrylic material. The central optic and rings seemed non compromised and the surgeon elected to not exchange the lens. Through follow up, additional information was received stating patient is very happy. Patient was informed of the defect, the doctor? S decision to not explant the lens and non-visually significant nature of it. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2648035-2020-00266
• MDR Report Key: 9851816
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-19
• Date of Report: 2020-03-18
• Date of Event: 2020-02-20
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-20
• Date Added to Maude: 2020-03-19
• 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: ROAD 402 NORTH, KM 4.2 ANASCO INDUSTRIAL PARK
• Manufacturer City: ANASCO PR 00610
• Manufacturer Country: US
• Manufacturer Postal Code: 00610
• 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: 2020-03-19
• Model Number: ZLB00
• Catalog Number: ZLB00U0160
• 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: 2020-03-19
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-19