MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-22 for BIOMEDICS 1 DAY (55%) STRIP (OCUFILCON D) manufactured by Coopervision Carribean Corporation.
[142677669]
The association between the coopervision device and the event is unconfirmed.
Patient Sequence No: 1, Text Type: N, H10
[142677670]
The patient states that in (b)(6) she experienced redness and a foreign body sensation in the left (os) eye and sought medical attention. The patient was prescribed cravit (levoflaxacin hydrate) and flumetholon (flourometholone) solutions. On (b)(6) the patient attended a different location for an unrelated visit, to obtain an eyeglass prescription. There were no abnormal findings, no adverse event identified and no instruction for a follow-up visit but medications were continued as they had been prescribed by a separate location. On (b)(6) the patient visited the practice to purchase contact lenses but was not seen for medical treatment. The patient advised the staff that she has recovered and had resumed contact lens use. Good faith efforts have been made to obtain additional information without success, additional information is unknown. This event is being reported in an abundance of caution due to incomplete diagnosis and lack of medical information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2640128-2019-00003 |
| MDR Report Key | 8537417 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-22 |
| Date Mfgr Received | 2019-03-24 |
| Device Manufacturer Date | 2018-04-02 |
| Date Added to Maude | 2019-04-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MELISSA TORPEY |
| Manufacturer Street | 5870 STONERIDGE DRIVE SUITE 1 |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 5857569874 |
| Manufacturer G1 | COOPERVISION CARRIBEAN CORPORATION |
| Manufacturer Street | 500 ROAD 584 LOT 7 |
| Manufacturer City | AMUELAS INDUSTRIAL PARK, 00795 |
| Manufacturer Postal Code | 00795 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOMEDICS 1 DAY (55%) STRIP (OCUFILCON D) |
| Generic Name | BIOMEDICS 1 DAY (55%) STRIP (OCUFILCON D) |
| Product Code | MVN |
| Date Received | 2019-04-22 |
| Returned To Mfg | 2019-03-27 |
| Lot Number | 1114570538 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERVISION CARRIBEAN CORPORATION |
| Manufacturer Address | 500 ROAD 584 LOT 7 AMUELAS INDUSTRIAL PARK, 00795 00795 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-22 |