800 in vitro 10 Set) W9 1997 11 1998 10 TC
( Brandvood  ) 1997 ( D 2 IS ) FDA口S Veb ( www f da. gov/cdrh/) ) ( ) ( Mcrosoft Access97 ( ) M crosof t   Access97 800 ar W & i ndows  NT Server Internet   Infornation Server (IIS) Acc ess Veb a) ( Mni mmData  Set 1994 b) ) i dent i t y i dent i t y c) ( ) ( 1996 6 , Buffal o) d) I SO 1) ( Mni mmDat a (I SQ 150 (I mpl ants for Surgery) V29 (Mni mmData Sets for Surgi cal   I npl ant s) Mni mumData Set ( 15 a) b) 15 c) d) i dent i t y e) f) g) h) i) si de) j) i dent i t y i dent i t y Mdi care  Card Soci al   Security  No Medi cal   Devi ce  Report i ng( MDR) ( www f da. gov/cdrh/) Veb 1993 3 ( AI C) ( Adverse Incident Centre ) 36 Veb 1996 Hazard   Safety Notice Device Bull et i n Access 1998 4000 1995 CT Hazard  Safety Noti Devi ceBul l et i n ce ( www nedi cal - devi AI C ces. gov. uk/) AM P M FDA   Mdi cal   Devi ce  Report i ng FDA    MdVsit ch ) ( 800 Excel Veb I SO Mni mmDat a  Set i dent i t y 7 Brandvood Veb Mchi o  Sat o  and  Aki t ada  Nakamura, "Device Tracking and Retrieval in Japan", Proceedings of ID:3 - I npl ant  Dat a:   Record,   Report, Revi ew   1996 I SO'TC150/V09/N26,   " M ni mm Dat a Sets for Surgical Inplants", ISO IS 16054 MA Crosbi e TGA
1993-96 IOL (MDR)
96/06/03 11111] Date Received Access Number Access Type xxx INTRAOCULAR LENS Pro Street i Manufacturer Name KYY Model n Report type SERIOUS INJURY Catalog num be FDA panel code   DG FDA Product code   HOL
Event description ENS REPLACEMENT DUE TO ACUTE CORNEAL DECOMPENSATION AND CORNEAL TOU VITRECTOMY, CORNEAL TRANSPLANT, AND LENS SUTURING WERE PERFORMED. THE PHYSICIAN FELT THIS TO BE PRODUCT RELATED.
THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. IN ADDITION, AVAILABLE FREQUENCY AND SRVERITY DATA DO NOT INDICATE THAT ANY FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. BOTH THE FREQUENCY AND SEVERITY OF THIS EVENT WILL BE PERIODICALLY MONITORED TO DETERMINE IF ANY FOLLOW-UP AND/OR OTHER ACTION IS INDICATED.
Mdi cal   Devi ce  Report i ng
Medical Devices Agency (MDA), An Executive Agency of the Department of Health Hannibal House, Elephant and Castle, London SE1 6TQ, England
10

Notified  Body Medical Devices Agency 1997 (MDA) Notified  Body Manufacturer Registration Scheme MDA (MRS)  Clinical  Device Technology and Safety Device (DTS) Evaluation and Publication (DEP) European and Regulatory Affairs (ERA) Business  Group 33 MDA 120 Notified   Body Annual Report and "vigilance system" Accounts European & Regulatory Affairs Group Directives Bulletins MDA Guidance Notes MDA EU Standard Directive PDF MDA http://www.open.gov.uk/mda/ mdahome.htm Acrobat Reader CE MDA 1993 Windows 1994 yes, no 1998 13 1995 Device Technology and Safety ( in vitro Implant & Material Section Adverse Incident Centre section 80 MDA 1998 MDA Standard ) Implant & Material Section MDA 42 ; ; AIC ; ; ; 12 4000 1995 CT MDA MDA Hazard Hazard Notice Hazard Device Bulletin Safety Björk-Shiley   C-C AIC AM PM MDA AIC Device Evaluation and Publication (DEP) DEP ) Adverse Incident Centre (AIC) ( AIC Hazard Safety Notice Bulletin Device Evaluation Report 980 ONS Office for National  Statistics
200 DEP 20 60 Stimulator ___ Björk-Shiley    C-C Liverpool Walton 1986 Hammersmith MDA Trent Trent
26 95% 90 70 90% 20% MDA 13,500 8,500 10 51335 57830
ONS
1993 ONS UNIX Oracle Microsoft Access 2.0 EPS for Windows Brompton 1978 1960 1982 dBASE Brompton (http://ww.rbh.nthames.nhs. uk/) 130 15,000 153,000 125,000 35% 40 MDA FT-IR 13 Salisbury 1993 No delamination MDA 95 94
Safety Notice MDA Sheffield Hallamshire MDA 1989 900 40 1990 2 4 50 MDA — DOS 10 ISO National Health Service NHS MDA Medicare card ONS Office for National  Statistics