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Adverse Event Report

ALCON MANUFACTURING, LTD.   back to search results
Event Date 03/27/1996
Event Type  Injury  
Manufacturer Narrative

H-10: no product was returned for eval at time of initial event. No adverse event was reported. H-11: partial info in section f provided by customer's initial report. Codes provided by mfr. This report was mailed in to fda on: 5/23/97. Disclaimer: this info is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an alcon laboratories, inc. Product is defective or has caused serious injury.

 
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Baseline Brand NameSERIES TEN THOUSAND COMPACT
Baseline Generic NameOPHTHALMIC SURGERY SYSTEM
Baseline Catalogue NumberSTTC
Baseline Model NumberSTTC
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 G)
ALCON MANUFACTURING, LTD.
15800 alton pkwy.
irvine CA 92618 3818
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134
(817) 551 -8317
Device Event Key92320
MDR Report Key93500
Event Key87928
Report Number2028159-1997-00082
Device Sequence Number1
Product CodeHQE
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative,Distributor
Remedial Action Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/1997
Date Manufacturer Received04/23/1997
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is the Device an Implant? No
Type of Device Usage Reuse

Database last updated on February 28, 2009

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