Brand Name | RAYONE ASPHERIC |
Type of Device | RAYONE ASPHERIC |
Manufacturer (Section D) |
RAYNER INTRAOCULAR LENSES LIMITED |
the ridley innovation centre |
10 dominion way |
worthing, west sussex BN14 8AQ |
UK BN14 8AQ |
|
Manufacturer (Section G) |
RAYNER INTRAOCULAR LENSES LIMITED |
the ridley innovation centre |
10 dominion way |
worthing, west sussex BN14 8AQ |
UK
BN14 8AQ
|
|
Manufacturer Contact |
jodie
neal
|
the ridley innovation centre |
10 dominion way |
worthing, west sussex BN14 -8AQ
|
UK
BN14 8AQ
|
|
MDR Report Key | 10579955 |
MDR Text Key | 208375057 |
Report Number | 3012304651-2020-00021 |
Device Sequence Number | 1 |
Product Code |
HQL
|
UDI-Device Identifier | 05029867691591 |
UDI-Public | (01)05029867691591 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | P060011 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
09/24/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | RAO600C |
Device Catalogue Number | RAO600C |
Device Lot Number | 040152667 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/22/2020 |
Initial Date FDA Received | 09/24/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|