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Adverse Event Report

CIBA VISION CORP. CIBA VISION MEMORY LENS INTRAOCULAR LENS   back to search results
Model Number CV232 SRE
Device Problem Lens, repositioning of
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Prior to insertion of the intraocular lens, the patient experienced two peripheral capsule tears during the capsullorhexis. The surgeon converted to an ecce and implanted the lens into the ciliary sulcus. Two days post-operative, the eye developed pupillary block. This was treated with mydriatic medication & the surgeon subsequently performed a surgical intervention using a spatula to reposition the lens through a paracentesis.

 
Manufacturer Narrative

H4 & h6: it is not possible to review the device history records and sterility records as the lens control number was not provided. The product insert data sheet indicates the following: the lens is intended for placement in the capsular bag. (placement of the lens is in sulcus is outside the stated intended use. ) the need for secondary iridectomy for pupiliary block may be prevented by one or more iridectomies at the time of iol implantation.

 
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Brand NameCIBA VISION MEMORY LENS
Type of DeviceINTRAOCULAR LENS
Baseline Brand NameCIBA VISION MEMORY LENS
Baseline Generic NameINTRAOCULAR LENS
Baseline Catalogue NumberCV232 SRE
Baseline Model NumberCV232 SRE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CIBA VISION CORP.
lot #2, po 1358
el jibaro industrial park
cidra PR 00739
Manufacturer (Section D)
CIBA VISION CORP.
lot #2, po 1358
el jibaro industrial park
cidra PR 00739
Manufacturer Contact
pat strahl
11460 johns creek parkway
duluth , GA 30097
(678) 415 -3816
Device Event Key442225
MDR Report Key453227
Event Key429249
Report Number2648694-2003-00040
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 03/13/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberCV232 SRE
Device Catalogue NumberCV232 SRE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/13/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/11/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,NONE REPORTED.,

Database last updated on February 28, 2009

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