Alcon recalls Custom Pak with potential 23GA ULTRAVIT probe included instead of 25GA. Check lot numbers 507492, 507539, 507664 for affected units.
Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a 25+ ULTRAVIT probe.
Alcon is recalling Custom Pak devices that may include a 23-gauge ULTRAVIT probe instead of the intended 25-gauge probe. This mismatch could cause improper use during eye surgery, potentially leading to complications.
The recall involves a potential inclusion of a 23-gauge ULTRAVIT probe instead of the required :25-gauge probe. Using the wrong probe size during eye surgery could lead to improper surgical outcomes or complications.
Surgical teams using Alcon Custom Pak for vitrectomy procedures are most at risk. Patients undergoing eye surgery with these kits may face complications due to the probe mismatch.
Check the lot numbers on the Custom Pak: 507492, 507531, 507664. The product includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
Identify the lot numbers on the Custom Pak: 507492, 507539, 507664.
The recall involves a potential inclusion of a 23-gauge ULTRAVIT probe instead of the intended 25-gauge probe in the Custom Pak.
Lot numbers 507492, 507539, and 507664 are affected.
The recall does not specify an immediate stop-use requirement; check the lot numbers to determine if your unit is affected.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-0779-2018 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-0779-2018 from Alcon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
