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Synergetics

SYNERGETICS USA, INC. · Model 55.29 · UDI-DI 20841305106912

HQB Prescription
10
510(k) clearances
68
Adverse events
32
Recalls
28
Facilities

Description

Curved MaxIllum Focused Laser Probe

Recalls

DateFirmReason
2025-12-16Vortex Surgical Inc.There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination
2025-12-16Vortex Surgical Inc.There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination
2025-11-19Vortex Surgical Inc.Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
2025-09-15Alcon Research LLCXXX
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
2013-12-09Synergetics IncFaulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.