BALANCED SALT SOLUTION ENDOSOL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2012-09-06 for BALANCED SALT SOLUTION ENDOSOL manufactured by Abbott Medical Optics.

Event Text Entries

[2995604] It was reported that the doctor performed a vitrectomy procedure on (b)(64) 2012, using endosol, balanced salt solution. It was stated that the patient presented with swelling and toxic syndrome on the anterior segment of the eye. It was reported by the doctor that endosol was involved, although the doctor did not think that the endosol is the reason for the adverse event. The patient was treated medically and reportedly recovered. Initially, the doctor reported to abbott medical optics (amo) that the patient was ok; however, it was later reported that the patient had a ''loss of vision and a long recovery process with serious risk involved. ' no further information was available at the time of submitting the medical device report.
Patient Sequence No: 1, Text Type: D, B5


[10130805] (b)(6). (b)(4). Prior to release to market, the endosol met all manufacturing specifications. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10


[10146853] Evaluation of the returned samples of amo endosol demonstrates that the product met specifications and release requirements. (b)(4) - the manufacturing record review indicated that the batch passed all acceptance criteria for all tests performed and was within specifications. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10


[18170318] Corrected data: (b)(6) 2012. All pertinent information available to the manufacturer has been submitted. Placeholder.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9614546-2012-00157
MDR Report Key2731611
Report Source01,05,06,07
Date Received2012-09-06
Date of Report2012-08-10
Date of Event2012-08-09
Date Mfgr Received2012-10-05
Device Manufacturer Date2012-03-12
Date Added to Maude2012-09-07
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 FDA0
Event Location0
Manufacturer ContactMS. STEPHANIE SOLOMON
Manufacturer StreetABBOTT MEDICAL OPTICS INC. 1700 EAST ST. ANDREW PLACE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal92705
Manufacturer Phone7145663731
Manufacturer G1.
Manufacturer StreetAMO GRONINGEN B.V. P.O. BOX 901
Manufacturer CityGRONINGEN 9700AX
Manufacturer CountryNL
Manufacturer Postal Code9700 AX
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBALANCED SALT SOLUTION
Generic NameSURGICAL ADJUNCTS
Product CodeKIP
Date Received2012-09-06
Returned To Mfg2012-09-20
Model NumberENDOSOL
Catalog NumberENDOSOL
Lot Number12C1203
Device Expiration Date2014-02-28
OperatorPHYSICIAN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MEDICAL OPTICS
Manufacturer AddressSANTA ANA CA


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2012-09-06

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