Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);

Alcon submitted three endoilluminators for vitreoretinal surgery: the 27GA Chandelier (hands-free wide-field illumination with tapered fiber), the 27+ DS Wide Angle Endoilluminator (sapphire lens with retractable dynamic stiffener), and the 27+ DS Endoilluminator (straight illuminator with dynamic stiffener). All are indicated for use during posterior segment ophthalmic surgery and transmit light energy into the eye.

The 27GA Chandelier differs from its 25GA predicate by gauge size (27 vs 25), resulting in smaller tip outer diameter (0.010" vs 0.014"), lower light transmission (0.096 vs 0.150 UFR), and different materials (ABS vs Polyimide). The 27+ DS Wide Angle uses sapphire, MP35N, and stainless steel with lower light transmission (0.047 vs 0.060 UFR), smaller tip (0.016" vs 0.020"), and shorter shelf life (2 vs 3 years). The 27+ DS Endoilluminator removes Teflon and cyanoacrylate adhesive from the predicate formulation while maintaining equivalent tip diameter and light transmission.

ISO 10993 (biocompatibility), ISO 11135 and ISO 10993-7 (ethylene oxide sterilization), ISO 11607-1 (packaging for sterilized devices), ASTM D4169 and F1980 (aging and shelf life), ISO 14971 (risk management), ISO 15004-1 (general ophthalmic instruments), ISO 15752 and ANSI Z80.36 (endoilluminator optical radiation safety).

The subject devices maintain the same intended use, indications, gauge size class (27GA), and basic function (light transmission for illumination) as their predicates. Although tip diameters and light transmission values differ slightly due to gauge upsizing or material changes, these differences are explained by the miniaturization inherent to 27-gauge design and do not raise new safety concerns. Biocompatibility, sterilization validation, and light hazard testing confirm functional equivalence. The removal of Teflon and adhesive in the 27+ DS model simplifies the design without affecting performance. All devices meet applicable ISO and ANSI standards comparably to their predicates.