Device adverse event reports (MAUDE)

RayOne EMV Toric · RayOne EMV Toric

Rayner Intraocular Lenses Limited · Difficult to Fold, Unfold or Collapse, Failure to Eject

MalfunctionInitial submissionMDR 50515029
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
  1. 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
  1. Patient sequence number
    1
    Date received
    20260831
    Patient age
    76 YR
    Patient sex
    Female
    Patient problems
    Corneal Edema
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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.