TECNIS ITEC PRELOADED 1-PIECE IOL PCB00 PCB0000220

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 2020-03-27 for TECNIS ITEC PRELOADED 1-PIECE IOL PCB00 PCB0000220 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[186169161] Age/date of birth: unknown, information not provided. Gender/sex: unknown, information not provided. If explanted, give date: not applicable, remains implanted in the eye. (b)(6). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10


[186169162] It was reported that the intraocular lens (iol) was implanted after correct set-up of the unit using healon pro as per direction for use. Doctor discovered a particle later and removed it without expanding wound or anything. As per the surgeon it is unclear if the particle came from the healon pro or the iol. No further information provided. This mdr report pertains to the suspect iol. A separate report will be submitted for the suspect healon pro.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2648035-2020-00294
MDR Report Key9892078
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-02-25
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-28
Date Added to Maude2020-03-27
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 ITEC PRELOADED 1-PIECE IOL
Generic NameMONOFOCAL IOLS
Product CodeHQL
Date Received2020-03-27
Model NumberPCB00
Catalog NumberPCB0000220
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 Received2020-03-27
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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