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Adverse Event Report

BAUSCH & LOMB SURGICAL, INC. HYDROVIEW INTRAOCULAR LENS   back to search results
Catalog Number H60M
Device Problem Lens, opacification of
Event Date 08/19/2000
Event Type  Malfunction  
Event Description

Lens opacification postoperative. The lens remains implanted in the patient's eye.

 
Manufacturer Narrative

A2; a3; a4; unk (facility unable to provide information). Note: manufacturer did not receive a medwatch report.

 
Manufacturer Narrative

H6: eval results-(other): stereomicroscopic analysis revealed a very light deposit on the posterior surface. The anterior surface was also light with a heavier deposit at the tip of the forceps marks.

 
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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., n.
clearwater FL 33759
Manufacturer (Section D)
BAUSCH & LOMB SURGICAL, INC.
21 park place blvd., n.
clearwater FL 33759
Manufacturer Contact
christine posin
21 park place blvd., n.
clearwater , FL 33759
(727) 724 -6661
Device Event Key287059
MDR Report Key296570
Event Key278549
Report Number1119279-2000-00230
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/13/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date08/01/1999
Device Catalogue NumberH60M
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/01/2001
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/1997
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 January 30, 2009

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