Brand Name | PROCLEAR TORIC, +0.75-2.25X30 8.4/14.4 UNK |
Type of Device | LENSES, SELF CONTACT, DAILY WEAR |
Manufacturer (Section D) |
COOPERVISION INC. |
scottsville NY 14546 |
|
MDR Report Key | 7650221 |
MDR Text Key | 112867449 |
Report Number | MW5078145 |
Device Sequence Number | 1 |
Product Code |
LPL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/27/2018 |
2 Devices were Involved in the Event: |
1
2
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 12/30/2020 |
Device Lot Number | 10336500009503 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 06/28/2018 |
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 41 YR |
|
|