EYE PROTECTION SHIELD 8888501219

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-02-02 for EYE PROTECTION SHIELD 8888501219 manufactured by Alcon -fort Worth.

Event Text Entries

[18610890] The facility reported that the dual eye shield was too loose, causing the lasik caps to be displaced in four cases; additional surgery required. Additional info has been requested. This pt is being reported under mfr. Report # 1610287-2007-00005. The other pts are being reported under mfr. Report #'s 1610287-2007-00002, 1610287-2007- 00003, 1610287-2007- 00004.
Patient Sequence No: 1, Text Type: D, B5


[18698397] Product was not available for evaluation. The supplier of the eye protection shields has been notified of these events. Unable to determine root cause from this investigation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1610287-2007-00005
MDR Report Key812176
Report Source05
Date Received2007-02-02
Date of Report2007-01-05
Date Mfgr Received2007-01-05
Date Added to Maude2007-02-06
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 Location0
Manufacturer ContactMICHAEL BUENGER
Manufacturer Street6201 SOUTH FREEWAY
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8175516810
Manufacturer G1ALCON LABORATORIES, INC.
Manufacturer Street6201 SOUTH FREEWAY
Manufacturer CityFORT WORTH TX 76134209
Manufacturer CountryUS
Manufacturer Postal Code76134 2099
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameEYE PROTECTION SHIELD
Generic NameEYE PROTECTION SHIELD
Product CodeHOY
Date Received2007-02-02
Model Number8888501219
Catalog Number8888501219
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key799659
ManufacturerALCON -FORT WORTH
Manufacturer Address6201 SOUTH FREEWAY FORT WORTH TX 761342099 US
Baseline Brand NameEYE PROTECTION SHIELD
Baseline Generic NameEYE PROTECTION SHIELD
Baseline Model No8888501219
Baseline Catalog No8888501219
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2007-02-02

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