Ocuserv neglects to validate software transfer process for ophthalmic autoscan system.

Software validation was the principal concern noted by FDAers following a Jan. 13, 14 and 23 inspection at Ocuserv Instruments, Jamaica, NY, which resulted in a warning letter dated March 2.

Agency investigators found that the manufacturer of ultrasonic imaging systems--Autoscan DB 3000 and DB 3000C Biometric Rulers, Ophthalmic A-Scan Systems--had not only failed to document process validation results and activities for the devices but had neglected to validate software transfer processes.

For example, the software transfer process using the firm's ChipMaster 3000 (V.2.61) programmer had not been validated to assure that it was capable of reproducing and completely copying the master software program onto a blank chip that would subsequently be installed into the finished device, an Ophthalmic Autoscan DB 3000C System. The autoscan systems are software driven and measure the axial length of the eye, anterior chamber depth, and lens thickness plus calculate the power of an intraocular lens that replaces the eye's natural lens after cataract surgery.

Other violations cited in the warning letter included failure to establish and maintain an adequately written Device Master Record; failure to establish the appropriate responsibility, authority and interrelation of all personnel who manage, perform and assess workaffecting quality; failure to establish, maintain and implement procedures for finished device acceptance; and failure to establish, maintain and implement procedures for acceptance of incoming products.

Moreover, Ocuserv had failed to establish procedures for quality audits; failed to ensure that manufacturing equipment was routinely calibrated, inspected, checked and maintained; and failed to establish and maintain instructions and procedures for performing and verifying that servicing meets the specified requirements.

Other procedural failures listed in the warning letter included that no written procedures were established directing the maintenance of service records; there were no procedures for receiving, reviewing and evaluating complaints by a formally designated unit; there were no procedures for implementing corrective and preventative actions; there were no procedures for addressing the identification, documentation, evaluation, segregation, disposition and investigation of all non-conforming device products; and there were no procedures for component acceptance activities or for the control, approval and distribution of all documents.

In a telephone interview, Ocuserve President Moshko Fuchs said: "We are at this time working closely with FDA to address all of the issues in the letter." Doc. 12910W