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Rayner Intraocular Lenses Ltd Recall 90301

Description: RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D.

Rayner Intraocular Lenses Ltd Recall 90301 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1338-2022
Event ID90301
Event DescriptionRayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D.
Product TypeDevices
DistributionUS Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO, ND, NJ, OK, TN, and TX.
Quantity162 IOLs
Recall ReasonThe outer package is mislabeled and the package contains a different IOL strength.
Device Classification20220713
Device Code InfoOuter carton +19.0 D - Batch #012183745, exp. 1/17/2024, Serial numbers 01-06, 10, 21, 24-45, 48-53, 58-60, 61-65, and 68-81, UDI (01)05029867006685. Outer carton +21.0 D - Batch #012183845, exp. 1/17/2024, all serial numbers, UDI (01)05029867006722.
Center Classification Date20220706
Recall Initiation Date20220513
Recalling FirmRayner Intraocular Lenses Ltd
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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