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 2019-11-25 for ACUVUE? OASYS? PH manufactured by Johnson & Johnson Vision Care, Inc. ? Us.
[185037284]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185037285]
On 05nov2019 a letter was received from the fda, mw5090524. An eye care provider (ecp) reported a patient (pt) presented emergently with significant corneal and conjunctival inflammation, discomfort and reduced vision from? Overwearing and misuse of contact lenses.? The pt was wearing acuvue? Oasys? Brand contact lenses at the time of the event. The pt had not had an eye exam or contact lens evaluation in more than 10 years. The pt continued to regularly order contact lenses on-line and receive contact lenses without a valid contact lens prescription. The ecp advised that the pts prior prescribing ecp had retired 5 years earlier and closed the practice, no prescription verification would have been possible. No additional medical information was provided. No contact details were provided. No additional medical information is expected. The date of the event is reported as (b)(6) 2019. It is unknown which was the affected eye. The suspect lot number was not provided. No evaluation can be conducted. It is unknown if the suspect contact 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 | 1057985-2019-00136 |
| MDR Report Key | 9372513 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2019-11-25 |
| Date of Report | 2019-11-05 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2019-11-05 |
| Date Added to Maude | 2019-11-25 |
| 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 | 2019-11-25 |
| Model Number | NA |
| Catalog Number | PH |
| Lot Number | UNK-PH |
| 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 | 2019-11-25 |