PV Bulletin

Eyefill C Viscoelastic Product Recall - Bausch & Lomb

Bausch + Lomb has initiated a voluntary recall of specific lots of the Eyefill C viscoelastic ophthalmic device due to potential sterility compromise.

Primary source: Téléchargez le courrier de la société Bausch & Lomb (03/09/2026)

Translated From French

PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.

PV Impact Brief

Urgency: HighConfidence: high

What changed

Voluntary recall initiated for specific Eyefill C device lots due to potential sterility issues.

Why it matters

There is a risk of irreversible eye damage if a compromised viscoelastic device is used during cataract surgery, even without any reported patient injuries.

Action needed

Healthcare establishments must quarantine the affected Eyefill C lots, refrain from using them, and monitor patients who received the device.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 3, 2026

Full briefing

Practical implication

Healthcare establishments must quarantine the affected Eyefill C lots, refrain from using them, and monitor patients who received the device.

On September 3, 2026, the French medicines regulator ANSM announced that Bausch + Lomb is recalling certain lots of its Eyefill C device (SKU EYEFILL-C-B) following reports of damaged blisters containing pre-filled syringes, which may compromise sterility. Affected lots must be quarantined immediately, and while no patient impact has been reported, monitoring post-operative patients who received the affected product is necessary.

What changed: Voluntary recall initiated for specific Eyefill C device lots due to potential sterility issues.

Why it matters: There is a risk of irreversible eye damage if a compromised viscoelastic device is used during cataract surgery, even without any reported patient injuries.

Practical implication: Healthcare establishments must quarantine the affected Eyefill C lots, refrain from using them, and monitor patients who received the device.

View original source

  • Source: ANSM (France) - Safety information feed
  • Published at source: 2026-09-03T00:00:00.000Z
  • Discovered by monitor: 2026-09-03T21:47:55.806Z

Published from the regulator source ingestion pipeline after PV impact triage.

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