TECNIS ITEC PRELOADED 1-PIECE IOL PCB00 PCB0000170

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-25 for TECNIS ITEC PRELOADED 1-PIECE IOL PCB00 PCB0000170 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[186565822] Age/date of birth: unknown/not provided. Sex/gender: unknown/not provided. If implanted, if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery. (b)(4). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10


[186565823] It was reported that the trailing haptic of an intraocular lens (model pcb00 17. 0 diopter) was amputated during insertion into the patient's left eye (os). The lens was cut in two pieces and was removed. The incision was enlarged and sutures were required. There was no patient injury reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2648035-2020-00274
MDR Report Key9879415
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2019-12-12
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 ITEC PRELOADED 1-PIECE IOL
Generic NameMONOFOCAL IOLS
Product CodeHQL
Date Received2020-03-25
Model NumberPCB00
Catalog NumberPCB0000170
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
101. Required No Informationntervention 2020-03-25

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