Recall Z-2063-2020 ยท HQG Lens, Spectacle, Non-Custom (Prescription)
Frames Direct
Frames Direct Prescription Spectacle Lenses included in the frame brands
| Date | Mar 18, 2020 |
| Status | Terminated |
| Reason | The firm has become aware through their optical laboratory supplier that prescription spectacle lenses within various frames failed to meet safety specification for shatter resistance. This could result in cracked or broken lenses. |
| Root cause | Process control |
| Action | On 03/24/20, FramesDirect.com sent a "Urgent Medical Device recall letter via certified mail to affected consignees. The firm also emailed and phoned each affected consignee on 3/20/20. In addition to informing consignees about the recalled spectacle lenses, they asked consignees take the following action: Please discontinue use of these eyeglasses immediately and return them as soon as possible using the prepaid UPS label enclosed. The order numbers listed below have been included in this urgent medical device recall. |
| Quantity | 87 pair |
| Distribution | US: Alabama,Arizona,California,Colorado,Florida,Georgia,Hawaii,Idaho,Illinois,Indiana,Kansas,Kentucky,Louisiana,Maine,Maryland,Massachusetts,Michigan,Mississippi,Missouri,Montana,Nevada,New Jersey,New Mexico,New York,North Carolina,Ohio,Oklahoma,Oregon,Pennsylvania,Puerto Rico,South Carolina,Texas,U |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.