Description of Event or Problem · 0
MANUFACTURER FAILURE TO FOLLOW-UP AND PROVIDE WRITTEN CLARIFICATION AND INSTRUCTIONS FOR CLEANING, DISINFECTION AND STERILIZATION OF THEIR FDA APPROVED CONTACT AND NON-CONTACT LENSES PER SPAULDING CLASSIFICATION. THESE LENSES ARE A REUSABLE MEDICAL DEVICE THAT REQUIRES THE UTMOST ATTENTION TO DETAIL IN FOLLOWING MANUFACTURER INSTRUCTIONS FOR USE AND EVIDENCE BASED GUIDELINES FOR CLEANING, DISINFECTION AND STERILIZATION IN ORDER TO ENSURE SAFE USE ON A PATIENT AND TO MITIGRATE THE POTENTIAL RISK OF COLONIZATION, INFECTION AND HARM. PER PUBLISHED INSTRUCTION FOR USE ALL NON-CONTACT AND CONTACT LENSES REQUIRE HIGH LEVEL DISINFECTION MINIMALLY WITH A COMPATIBLE DISINFECTING SOLUTION SUCH AS CIDEX OPA. SUPPLEMENTAL DOCUMENTATION WAS PROVIDED BY POINT OF CONTACT WITH MANUFACTURER BUT DIRECTION HAS NOT BE PROVIDED TO CLARIFY BASED ON INTENDED USE FOR EITHER CONTACT WITH MUCOUS MEMBRANES OR NOT PER EVIDENCE BASED GUIDELINES. THE DOCUMENT ONLY ALLOWS FOR A SPECIFIC CLEANING AND DISINFECTING WIPE, REQUEST WAS MADE ON SEVERAL OCCASIONS BOTH VIA EMAIL AND PHONE REQUESTING TESTING OF OTHER SIMILAR CLEANING AND DISINFECTING WIPES ON THE MARKET. RESULTING COMMUNICATIONS PROVIDED LIMITED DIRECTION, AND SUBSEQUENT REQUESTS FOR FURTHER CLARIFICATION AND TESTING WAS SUBMITTED. NO RESPONSE TO DATE. PER REGULATORY ACCREDITATION OVERSIGHT ANY CLARIFICATION OF AMBIGUOUS INSTRUCTIONS FOR USE MUST BE OBTAINED FROM THE HEALTH CARE ENTITY VIA THE MANUFACTURER. THEREFORE, REQUESTING ASSISTANCE IN OBTAINING UPDATED INSTRUCTIONS AND CLEARLY DEFINED COMPATIBLE PRODUCTS TO ENSURE PATIENT AND EMPLOYEE SAFETY VIA FDA FOR SUPPORT. MANUFACTURER RESPONSE FOR NON-CONTACT (BIO & SLIT LAMP) AND CONTACT GONIO LENSES, NON-CONTACT (BIO & SLIT LAMP) AND CONTACT GONIO LENSES (PER SITE REPORTER) THE MANUFACTURE REFUSES TO PROVIDE CLEAR INSTRUCTIONS FOR USE DESPITE OUR MANY REPEATED REQUESTS AND DESPITE THE REGULATORY WARNINGS FOR PROPER CLEANING INSTRUCTIONS FOR EYE DEVICE TO AVOID INFECTIONS.