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Adverse Event Report

BAUSCH & LOMB, INC. HYDROVIEW INTRAOCULAR LENS   back to search results
Catalog Number H60M
Device Problems Calcification; Device remains implanted
Event Type  Malfunction  
Event Description

Presumed calcification. Original surgery date in 2001. Lens remains implanted.

 
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Brand NameHYDROVIEW INTRAOCULAR LENS
Type of DeviceINTRAOCULAR LENS
Baseline Brand NameHYDROVIEW INTRAOCULAR LENS
Baseline Generic NamePOSTERIOR CHAMBER IOL
Baseline Catalogue NumberH60M
Baseline Model NumberH60M
Other Baseline ID NumberYG
Baseline Device FamilyHYDROVIEW POSTERIOR CHAMBER INTRAOCULAR LENS
Baseline Device 510(K) Number
Baseline Device PMA NumberP990014
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed09/30/1995
Manufacturer (Section F)
BAUSCH & LOMB, INC.
rochester NY 14609
Manufacturer (Section D)
BAUSCH & LOMB, INC.
rochester NY 14609
Manufacturer (Section G)
BAUSCH & LOMB
21 park place blvd. n
clearwater FL 33759
Manufacturer Contact
kathy holland
3365 tree court ind. blvd.
st. louis , MO 63122-6694
(636) 226 -3227
Device Event Key506902
MDR Report Key517871
Event Key491410
Report Number1920664-2004-00079
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 01/07/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberH60M
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/07/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on January 30, 2009

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