MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2019-11-14 for ACUVUE? OASYS? PH manufactured by Johnson & Johnson Vision Care, Inc. ? Us.
[185033798]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185033799]
On 29oct2019 an email was received from the fda, mw5090302 with information received from an eye care provider (ecp) who reported a new patient (pt) presented with significant corneal and conjunctival inflammation, discomfort and reduced vision on (b)(6) 2019 while wearing an acuvue? Oasys? Brand contact lens. The pt was? Over-wearing and misusing? The contact lenses and had not had an eye exam or contact lens evaluation in more than 10 years. The pts prior prescribing ecp retired 5 years ago and the office was closed. The pt continued to receive contact lenses from an on-line provider without a valid prescription or prescription verification from the on-line provider. The emergent office visit revealed corneal edema, corneal staining and corneal neovascularization. No additional medical information was provided. The lot number of the suspect product was not provided. Multiple attempts were made to the reporting ecp for additional medical and product information, but nothing additional has been provided. It is unknown if the suspect lens is available for return for evaluation. If any further relevant information is received, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057985-2019-00123 |
| MDR Report Key | 9324649 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2019-11-14 |
| Date of Report | 2019-10-29 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2019-10-29 |
| Date Added to Maude | 2019-11-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROSE HARRELL |
| Manufacturer Street | 7500 CENTURION PARKWAY |
| Manufacturer City | JACKSONVILLE FL 32256 |
| Manufacturer Country | US |
| Manufacturer Postal | 32256 |
| Manufacturer Phone | 9044433364 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUVUE? OASYS? |
| Generic Name | LENSES, SOFT CONTACT, EXTENDED WEAR |
| Product Code | LPM |
| Date Received | 2019-11-14 |
| Model Number | NA |
| Catalog Number | PH |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON VISION CARE, INC. ? US |
| Manufacturer Address | 7500 CENTURION PARKWAY JACKSONVILLE FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-11-14 |