MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for HUBBLE CONTACT LENSES SPHERE LENSES manufactured by Hubble Contact Lenses/ St. Shine Optical Co., Ltd.
[176950516]
Patient presented with reduced vision that was not correctable with glasses. She reported that her last exam was over 3 years ago and was currently getting her glasses online without a prescription from https://www. Hubblecontacts. Com. The lens was not a good fit for either eye and was causing inflammation to the front surface. Her best correction was not 20/20 anymore and she was seeing double. Currently under rehabilitation to fix her cornea due to the improper fitting of the lens. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092565 |
| MDR Report Key | 9641490 |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-24 |
| Date Added to Maude | 2020-01-29 |
| 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 | LENSES, SOFT CONTACT, DAILY WEAR |
| Product Code | LPL |
| Date Received | 2020-01-28 |
| Model Number | SPHERE LENSES |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HUBBLE CONTACT LENSES/ ST. SHINE OPTICAL CO., LTD |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-28 |