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MDA/2007/055 - Contact lens solution: COMPLETE® MoisturePLUS™ from Advanced Medical Optics (AMO)

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/055
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 6
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 18 June 2007 at 14:00
Ref: MDA/2007/055


 
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Device:
Contact lens solution: COMPLETE® MoisturePLUS™ from Advanced Medical Optics (AMO).

>Page 2

Problem:
Worldwide product recall. This product is associated with an increased incidence of Acanthamoeba keratitis.

>Page 2

Action by:
Ophthalmologists, pharmacists, opticians, and optometrists who:

  • supply contact lens solutions
  • manage individuals who wear soft contact lenses
  • see patients with keratitis who wear soft contact lenses.
  

Action:

  • Do not supply COMPLETE® MoisturePLUS™ contact lens solution.
  • See detailed actions on page 2.

>Page 2

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI)  - Headquarters
Primary care trusts in England - Chief Executives*
Health Protection Agency (HPA) - Directors

* via CE Bulletin

>Page 2

Contacts:
Details of manufacturer contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

>Page 3

Appendix:
Advanced Medical Optics suppliers letter (Appendix 1) and user letter (Appendix 2).

>Pages 5-6



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 26 June 2007
Deadline (action complete): 19 July 2007


Page last modified: 07 February 2008