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Adverse Event Report

BAUSCH & LOMB SURGICAL ASC DAY PACK 10 PROCEDURES SURGICAL ACCESSORY   back to search results
Model Number DP5000
Device Problem Device remains implanted
Event Date 05/14/2000
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The surgeon reported hypopyon and endophthalmitis at approximately 1 month postoperative. The lens remains implanted. Pt has not been seen since the diagnosis. No other info is provided. The cause of hypopyon is unknown at this time. The surgeon reported this event to all mfrs because the products were used in the surgery.

 
Manufacturer Narrative

H3. Eval summary: product was not received for eval. The lens remains implanted in the pt's eye. No conclusion can be drawn at this time. This is the first of four events for the same product reported from the same account. Two other mdr's have also been filed for this same pt for two different products. (see mdr #1119279-2000-00168 and #1119279-2000-00169).

 
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Brand NameASC DAY PACK 10 PROCEDURES
Type of DeviceSURGICAL ACCESSORY
Baseline Brand NameASC DAYPACK 10 PROCEDURES
Baseline Generic NameSURGICAL PHACOEMULSIFICATION PACK
Baseline Model NumberDP5000
Baseline Device FamilySURGICAL ACCESSORY
Baseline Device 510(K) NumberK894278
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed01/04/1994
Manufacturer (Section F)
BAUSCH & LOMB SURGICAL
21 park place blvd., north
clearwater FL 33759
Manufacturer (Section D)
BAUSCH & LOMB SURGICAL
21 park place blvd., north
clearwater FL 33759
Manufacturer Contact
n grady
21 park place blvd., n
clearwater , FL 33759
(727) 724 -6643
Device Event Key274568
MDR Report Key283733
Event Key266152
Report Number1119279-2000-00170
Device Sequence Number1
Product CodeKYG
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 06/02/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/28/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberDP5000
Device Catalogue NumberDP5000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/02/2000
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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