LASIK Irrigation Cannula Recalled for Potential Temperature Exposure Damage
Beaver-Visitec medical irrigation cannulas used in LASIK eye surgery are being recalled due to storage temperature excursions. Units distributed from June through September 2021 may have reduced effectiveness.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with theoretical risk of effectiveness degradation due to temperature exposure during storage. No reported injuries or confirmed failures. Classified as High because this is a critical surgical tool for eye surgery where reduced effectiveness could compromise surgical outcomes, but actual harm has not been documented.
Plain-English summary
Beaver-Visitec International's Visitec LASIK Irrigation Cannulas (catalog #585278, GTIN 30886158002995) are being recalled due to potential damage from temperature excursions that occurred during storage prior to product delivery.
From June through August 2021, the storage facility experienced higher than appropriate temperatures. Exposure to these elevated temperatures may have impacted the product's effectiveness. Because of this potential impact on device performance, the company is recalling all units that were received between June 1, 2021 and September 30, 2021.
The product is distributed nationwide throughout the United States. Healthcare facilities and providers who received affected units should contact their supplier or the manufacturer for information on product replacement or proper disposition.
No injuries or adverse events have been reported as of this recall notice. Patients and healthcare providers should address any concerns about affected devices with their medical team.
The recalled product
- Product
- BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS Catalog #585278
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-damage
- effectiveness-degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN: 30886158002995
- 00886158002994 EA
Distribution
Distributed nationwide across the United States.
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