RAYSERT PLUS INJECTOR— 510(k) K141091

Clearance details

Applicant

Rayner Intraocular Lenses , Ltd.

Product code

Code MSS

Device class

Class 1

Regulation

21 CFR 886.4300

Advisory panel

Ophthalmic

Date received

2014-04-28

Decision date

2014-05-28

Decision

Substantially Equivalent

Clearance type

Special

Location

Hove, E. Sussex, GB

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• K143307 — RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector2014-12-18
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• K091507 — RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/182009-12-04

Injury

385

Malfunction

2,033

Total

2,418

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• 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 that allow the use of these injectors in their approved labelling.Class II·Ongoing·Rayner Intraocular Lenses Limited·20200317

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141091.