TECNIS 1-PIECE ZCB00 ZCB0000220

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 2020-03-26 for TECNIS 1-PIECE ZCB00 ZCB0000220 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[184995186] Additional information: if explanted; give date: not applicable as the iol was not explanted, it remains implanted in the patient's eye. Device evaluation: product testing could not be performed because the product was not returned as the iol remains implanted in the patient's eye. A product quality deficiency could not be confirmed. The reported issue was not verified. 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. Attempts were made to contact the customer account requesting additional information however, to date no 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


[184995187] It was reported zcb00 22. 0 diopter intraocular lens (iol) was implanted in the patient? S operative eye and there was a film stuck on the posterior side of the optic. The doctor was able to remove the film by going underneath the lens and using the irrigation/aspiration (i/a) handpiece. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2648035-2020-00286
MDR Report Key9882253
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-26
Date of Report2020-03-25
Date of Event2020-02-26
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-26
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-PIECE
Generic NameMONOFOCAL IOLS
Product CodeHQL
Date Received2020-03-26
Model NumberZCB00
Catalog NumberZCB0000220
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 Received2020-03-26
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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