MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for HUBBLE CONTACT LENSES manufactured by Hubble Contact Lens / St. Shine Optical Co. Ltd..
[176307268]
Hubble contact lens online company sold contact lenses to a (b)(6) y/o female who had never worn contact lenses ever before without a fitting and proper instruction. Pt wore contacts all day long which are low oxygen permeable and reused their daily disposable contact lenses due to lack of education and proper fitting. This occurred over a period of 4 to 6 months. In (b)(6) 2016 pt was initially seen and accepted higher spectacle prescription but felt too strong, within a few weeks came back. Today in (b)(6) 2020, she admitted she was using the hubble contacts which due to overuse and misuse may have cause increased and fluctuating prescription. Her risk of infection and blindness increased with this proper use. Also, hubble violated the contact lens policy that all pts need to be fitted by an eye care provider for contact lenses. (b)(4). Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092406 |
| MDR Report Key | 9621722 |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-20 |
| Date of Event | 2020-01-20 |
| Date Added to Maude | 2020-01-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUBBLE CONTACT LENSES |
| Generic Name | SOFT CONTACT LENSES |
| Product Code | LPL |
| Date Received | 2020-01-22 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HUBBLE CONTACT LENS / ST. SHINE OPTICAL CO. LTD. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-01-22 |