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Adverse Event Report

CHIRON VISION CORP. KELMAN OMNIFIT II UV IOL INTRAOCULAR LENS   back to search results
Catalog Number 2102S
Event Date 04/30/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Lens replacement due to acute corneal decompensation and corneal touch. A vitrectomy, corneal transplant and lens suturing were performed. Patient's prognosis is good.

 
Manufacturer Narrative

A4=unknown. Mfr completed section f. F13: manufacturer did not receive a medwatch report. H6: product was not returned to manufacturer for evaluation. "the medical device reporting regulations (21 c. F. R. Part 803, et seq) require chiron vision corp and others to report to the fda certain device and product related information. The submission of such information is without prejudice and does not constitute an acknowledgment of the validity or relevance of such information or an admission or indication that the subject device or product malfunctioned or was causally connected to any reported death or injury. ".

 
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Brand NameKELMAN OMNIFIT II UV IOL
Type of DeviceINTRAOCULAR LENS
Baseline Brand NameKELMAN OMNIFIT II UV IOL
Baseline Generic NameLENS, INTRAOCULAR
Baseline Catalogue NumberNA
Baseline Model Number2102S
Baseline Device FamilyP850059
Baseline Device 510(K) Number
Baseline Device PMA NumberP850059
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed07/31/1986
Manufacturer (Section F)
CHIRON VISION CORP.
555 west arrow hwy
claremont CA 91711
Manufacturer (Section D)
CHIRON VISION CORP.
555 west arrow hwy
claremont CA 91711
Manufacturer (Section G)
BAUSCH & LOMB SURGICAL, INC.
555 west arrow hwy.
claremont CA 91711
Manufacturer Contact
christine jordan
500 iolab drive
claremont , CA 91711
(909) 399 -1600
Device Event Key100085
MDR Report Key101677
Event Key95589
Report Number2023366-1997-00024
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/26/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date12/15/1993
Device Catalogue Number2102S
Device LOT Number121588
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/30/1997
Device Age8.6 yr
Event Location AMBULATORY SURGICAL Facility
Date Manufacturer Received06/02/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/1988
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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