Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
This recall has been terminated (originally issued February 1, 2017).
- Company
- Nidek Inc
- Recall Initiated
- February 1, 2017
- Terminated
- December 5, 2017
- Recall Number
- Z-1494-2017
- Quantity
- 29
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
Reason for Recall
During treatment planning, the procedure was programmed with an unintended (wrong) correction.
Distribution
Nationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY.
Lot / Code Info
Software version 1.11 and 1.12. Serial numbers of Affected devices: MNE0009; NVE0002; OH00295; NC00185; CAE0016; COE0008; MI00131; GA00241; CAE0007; VAE0004; MI00131; CAE0031; AZ00167; COE0011; CA00561; PAE0003; TN00168; MNE0009; WA00246; CAE0047; OHE0005; WAE0008; MI00244; NY00473; CAE0007; WAE0008; NVE0002; WA00233; CAE0016.
Root Cause
Software change control
Action Taken
Nidek sent a Recall notification letter dated February 1, 2017 to all affected consignees by certified mail method beginning February 2, 2017. Letters advised of the issue received from a complaint and the steps the user took that created the issue. To prevent the issue, the letters provide steps that should be taken. Nidek's Customer Support team will contact customers by phone or email. Customers with questions were instructed to contact Customer Service at 1-800-223-9044 or email ff_support@nidek.com.