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Adverse Event Report

BAUSCH & LOMB, INC. SOFPORT PLACEMENT SYSTEM INTRAOCULAR LENS DELIVERY DEVICE   back to search results
Catalog Number MP-28
Device Problems Haptic(s), broken; Lens replacement
Event Type  No Answer Provided   Patient Outcome  Required Intervention;
Event Description

After the lens was inserted into the pt's eye. It was noticed the haptic was broken in the sofport placement system. The incision was enlarged to remove and replace the lens.

 
Manufacturer Narrative

H6 - evaluation results: a sample lens was loaded and delivered without difficulty. No problem found.

 
Search Alerts/Recalls

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Brand NameSOFPORT PLACEMENT SYSTEM
Type of DeviceINTRAOCULAR LENS DELIVERY DEVICE
Baseline Brand NameSOFTPORT PLACEMENT SYSTEM
Baseline Generic NameFOLDER AND INJECTOR, INTRAOCULAR LENS
Baseline Catalogue NumberMP-28
Baseline Model NumberMP-28
Other Baseline ID NumberNONE
Baseline Device FamilyINTRAOCULAR LENS DELIVERY DEVICE
Baseline Device 510(K) NumberK970727
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)12
Date First Marketed05/01/2003
Manufacturer (Section F)
BAUSCH & LOMB, INC.
rochester NY 14609
Manufacturer (Section D)
BAUSCH & LOMB, INC.
rochester NY 14609
Manufacturer Contact
kathy holland
3365 tree court ind. blvd.
st. louis , MO 63122-6694
(636) 226 -3227
Device Event Key527816
MDR Report Key538550
Event Key511322
Report Number1920664-2004-00394
Device Sequence Number1
Product CodeMSS
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/15/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Invalid Data
Device EXPIRATION Date04/01/2005
Device Catalogue NumberMP-28
Device LOT NumberH410601
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/15/2004
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on December 31, 2008

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