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Adverse Event Report

ALCON-IRVINE TECHNOLOGY CENTER SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM   back to search results
Model Number STTL
Device Problem Error message given
Event Date 12/04/2000
Event Type  Malfunction  
Manufacturer Narrative

H-10: received two handpieces for further eval on 01/08/2001. Both handpieces were out of specification due to loose connectors, confirming performance reported by customer.

 
Event Description

Reporter noted tuning failed (received error code), converted to ecce and implanted iol. Case was prolonged. Cancelled subsequent cases.

 
Manufacturer Narrative

H-10: a company service representative checked the system and found it to meet its performance specifications. Two u/s handpieces are being returned for further eval. Codes provided by mfr and missing info included after discussion with reporter.

 
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Brand NameSERIES TWENTY THOUSAND LEGACY
Type of DeviceOPHTHALMIC SURGERY SYSTEM
Baseline Brand NameSERIES TWENTY THOUSAND LEGACY
Baseline Generic NameOPHTHALMIC SURGERY SYSTEM
Baseline Catalogue NumberSTTL
Baseline Model NumberSTTL
Baseline Device FamilyPHACO
Baseline Device 510(K) NumberK911808
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed06/25/1991
Manufacturer (Section F)
ALCON-IRVINE TECHNOLOGY CENTER
15800 alton pkwy.
irvine CA 92618
Manufacturer (Section D)
ALCON-IRVINE TECHNOLOGY CENTER
15800 alton pkwy.
irvine CA 92618
Manufacturer Contact
ned luce
6201 south freeway
fort worth , TX 76134-2099
(817) 568 -6470
Device Event Key302248
MDR Report Key312480
Event Key293724
Report Number2028159-2001-00001
Device Sequence Number1
Product CodeHQE
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/04/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSTTL
Device Catalogue NumberSTTL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/04/2000
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer12/04/2000
Date Manufacturer Received12/04/2000
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on February 28, 2009

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