Worthing, N/A, United Kingdom
Rayner Intraocular Lenses Limited recalls
3 recalls recorded since 2018, most recently on 13 May 2022. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 May 2022
- Reason
- The outer package is mislabeled and the package contains a different IOL strength.
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO, ND, NJ, OK, TN, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1338-2022
- 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
Ongoing Class II Medical devices
- Recall started
- 17 March 2020
- Reason
- RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. In addition to having an expiry of 2015 the LOT number on the inner tray is identified as V001.
- Distribution
- US nationwide distribution in the states of OH, FL, GA, MD, SC, NJ, PR, IN, ID and MN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1753-2020
- RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses t
Terminated Class II Medical devices
- Recall started
- 9 August 2018
- Terminated
- 24 November 2020
- Reason
- Firm become aware of reports of post-operative refractive errors following implantation of lenses.
- Distribution
- US in the states of MO
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3282-2018
- C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following phacoemulsification
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.