RAYSERT PLUS INJECTOR— 510(k) K141091

Substantially Equivalent

Rayner Intraocular Lenses , Ltd.

FDA 510(k) clearance K141091 for RAYSERT PLUS INJECTOR, Substantially Equivalent on 2014-05-28. Applicant: Rayner Intraocular Lenses , Ltd..

Clearance details

Applicant: Rayner Intraocular Lenses , Ltd.
Product code: Code MSS
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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Adverse events under product code MSS

product code MSS

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.