Rayner Intraocular Lenses Limited The Ridley Innovation Centre 10 Dominion Way Worthing United Kingdom Recalls
Showing 1-2 of 2 recalls
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
Firm become aware of reports of post-operative refractive errors following implantation of lenses.
On August 31 the firm sent letters to all customers (health care facilities) that have received lenses in this batch and instructed to quarantine any remaining unused lenses from the C-flex 570C +19.0D batch 017100825. Replacement, reimbursement or substitution is offered (as appropriate).
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 that allow the use of these injectors in their approved labelling.
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.
Rayner lntraocular notified customers on 03/17/2020 via "Urgent Medical Device recall" letter. The recall letter identified the affected product and lot number. The customers were asked to immediately quarantine and return the product.