Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the em
FDA device recall Z-0593-2013 · posted 2012-12-20 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Inc
- Reason for recall
- Posterior fluidics modules installed in the system may need to be recalibrated.
- Action taken
- "Urgent Product Recall" notification letters dated August 31, 2012 were issued via first class mail, e-mail, and/or phone calls to affected customers. The product issue and the field correction was provided. Customers in the US may contact 1-800 338-2020 for questions.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HQC
- Quantity affected
- 124 units
- Distribution
- Worldwide Distribution was made in the U.S., Canada, Australia, Singapore, Korea, Switzerland, France, Germany, United Kingdom, Portugal, Italy, Spain, Ireland, Africa, UAE, Jordan, Turkey, Ukraine, a
- Date initiated
- 2012-08-31
- Date posted
- 2012-12-20
- Date terminated
- 2013-07-11
- Location
- Rochester, NY
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STELLARIS PC VISION ENHANCEMENT SYSTEM (K101325) | Bausch & Lomb, Inc. | 2010-08-17 |