OK 3 CONTACT LENS
Received Jan 26, 1994
Report MW4000079 · MDR key 11115
Device
Manufacturer
Contex, Inc.Product problems
- False claim
- Nonstandard Device
Patient
*
Narrative
Description of Event or Problem
RPTR IS AN OPHTHALMOLOGIST WHO ATTENDED A SEMINAR. AT THE SEMINAR HE WAS INFORMED THAT LENSES ARE IDE DEVICES NOT INTENDED FOR GENERAL SALE AND USE. DR PROMPTLY REQUESTED A REFUND FROM THE CO AND DISCONTINUED SALES OF THE PRODUCT. RPTR INDICATED THAT HE WOULD ASSIST IN AN INVESTIGATION OF SHIPPING PRACTICES OF THE CO. HE STATED THAT THE FIRM HAS BEEN MARKETING THESE DEVICES SINCE 1982 FOR ORTHOKERATOLOGY USAGE. HE ALSO STATED IN THE SAME CONVERSATION ON 4/12/93 THAT THE FIRM IS ADVERTISING THESE LENSES IN "ALL THE JOURNALS."