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Adverse Event Report

BAUSCH & LOMB SURGICAL, INC. HYDROVIEW INTRAOCULAR LENS   back to search results
Model Number H60M
Device Problem Lens, opacification of
Event Date 02/01/2000
Event Type  Malfunction  
Event Description

Lens opacification observed at approximately 9 months post-op. Pt visual acuity at last examination was 20/30. The lens remains implanted in the pt's eye.

 
Manufacturer Narrative

Note: mfr did not receive a medwatch report.

 
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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 NumberYC
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 SURGICAL, INC.
21 park place blvd., north
clearwater FL 33759
Manufacturer (Section D)
BAUSCH & LOMB SURGICAL, INC.
21 park place blvd., north
clearwater FL 33759
Manufacturer Contact
christine posin
21 park place blvd., n.
clearwater , CA 33759
(727) 724 -6661
Device Event Key283509
MDR Report Key292909
Event Key275015
Report Number1119279-2000-00210
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 07/25/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date05/01/2000
Device MODEL NumberH60M
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/25/2000
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/1995
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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