TECNIS ZA9003 ZA90030110

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 ZA9003 ZA90030110 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[184930154] Age/date of birth: unknown/ not provided. Sex/gender: unknown/ not provided. Date of event: unknown, not provided. If implanted, give date: not applicable, as lens was removed/replaced during the same procedure. If explanted, give date: not applicable, as lens was removed/replaced during the same procedure. Initial report said that the device is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed. A review of the device/lot history record and complaint trending for this device will be performed. Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed. Attempts have been made to obtain missing information; however, no definitive response has been received. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10


[184930155] It was reported that a customer is returning the za9003 intraocular lens (iol) and emerald cartridge due to a complaint of a "film" on the za9003. It was stated that the customer is not sure if the film is on the lens or if it came from the cartridge. It was learned that the iol had patient contact and was removed but will not be returned. No other information was provided. This mdr report pertains to the iol suspect product. A separate report will be submitted for the cartridge suspect product.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2648035-2020-00277
MDR Report Key9880057
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-25
Date of Report2020-03-25
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-25
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
Generic NameMONOFOCAL IOLS
Product CodeHQL
Date Received2020-03-25
Model NumberZA9003
Catalog NumberZA90030110
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 Received2020-03-25
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.