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 Number2648035-2020-00266
MDR Report Key9851816
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-19
Date of Report2020-03-18
Date of Event2020-02-20
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-20
Date Added to Maude2020-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSOMYATA NAGPAL
Manufacturer Street1700 EAST ST. ANDREW PLACE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal92705
Manufacturer Phone7142478200
Manufacturer G1JOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer StreetROAD 402 NORTH, KM 4.2 ANASCO INDUSTRIAL PARK
Manufacturer CityANASCO PR 00610
Manufacturer CountryUS
Manufacturer Postal Code00610
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameTECNIS 1 MULTIFOCAL
Generic NameMULTIFOCAL IOLS
Product CodeMFK
Date Received2020-03-19
Model NumberZLB00
Catalog NumberZLB00U0160
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer Address1700 E. ST. ANDREW PLACE SANTA ANA CA 92705 US 92705

Device Sequence Number: 101

Product Code---
Date Received2020-03-19
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-19

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