RayOne EMV Toric · RayOne EMV Toric
Rayner Intraocular Lenses Limited · Difficult to Fold, Unfold or Collapse, Failure to Eject
- Manufacturer contact zip ext
- 8AQ
- Manufacturer g1 address 2
- 10 Dominion Way
- Manufacturer contact t name
- Mr.
- Manufacturer link flag
- Y
- Manufacturer contact address 2
- 10 Dominion Way
- Manufacturer g1 city
- Worthing, West Sussex
- Manufacturer contact address 1
- The Ridley Innovation Centre
- Event type
- Malfunction
- Report number
- 3012304651-2026-00253
- Product problem flag
- Y
- Date received
- 20260831
- Date of event
- 20260526
- Reprocessed and reused flag
- N
- Manufacturer contact zip code
- BN14
- Reporter occupation code
- PHYSICIAN
- Noe summarized
- 1
- Manufacturer contact l name
- Kota
- Manufacturer g1 postal code
- BN14 8AQ
- Reporter country code
- RP
- Date added
- 20260831
- Manufacturer contact f name
- Ambadas
- Device date of manufacturer
- 20260129
- Previous use code
- I
- Mfr report type
- Thirty-Day
- Manufacturer contact country
- UK
- Date changed
- 20260904
- Health professional
- Y
- Summary report flag
- N
- Manufacturer g1 zip code ext
- 8AQ
- Date report
- 20260831
- Initial report to FDA
- No
- Manufacturer g1 country
- UK
- Manufacturer contact city
- Worthing, West Sussex
- MDR report key
- 50515029
- Date manufacturer received
- 20260810
- Report source code
- Manufacturer report
- Manufacturer g1 zip code
- BN14
- Manufacturer g1 name
- Rayner Intraocular Lenses Limited
- Adverse event flag
- N
- Single use flag
- Y
- Manufacturer g1 address 1
- The Ridley Innovation Centre
- Manufacturer contact postal code
- BN14 8AQ
- Type of report
- Initial submission
- Source type
- Foreign, Health Professional, User facility
- Device
- Device sequence number
- 406254
- Implant date year
- 2026
- Date removed year
- 2026
- Date received
- 20260831
- Brand name
- RayOne EMV Toric
- Generic name
- RayOne EMV Toric
- Manufacturer d name
- Rayner Intraocular Lenses Limited
- Manufacturer d address 1
- The Ridley Innovation Centre
- Manufacturer d address 2
- 10 Dominion Way
- Manufacturer d city
- Worthing, West Sussex
- Manufacturer d zip code
- BN14
- Manufacturer d zip code ext
- 8AQ
- Manufacturer d country
- UK
- Manufacturer d postal code
- BN14 8AQ
- Device operator
- HEALTH PROFESSIONAL
- Model number
- RAO210T
- Catalog number
- RAO210T
- Lot number
- 016290603
- Device report product code
- HQL
- Device evaluated by manufacturer
- N
- Combination product flag
- N
- Harmonized identifiers (openFDA)
- Device name
- Intraocular Lens
- Medical specialty description
- Ophthalmic
- Regulation number
- 886.3600
- Device class
- 3
- Product problems
- Difficult to Fold, Unfold or Collapse, Failure to Eject
- Patient
- Patient sequence number
- 1
- Date received
- 20260831
- Patient age
- 76 YR
- Patient sex
- Female
- Patient problems
- Corneal Edema
