Bausch and Lomb Recall | Bausch and Lomb Recalls Eye Surgery Solution Due Serious Patient Injuries
The U.S. Food and Drug Administration (FDA) has issued a Class 1 Safety Alert Bausch and Lomb Recall Notice for Bausch and Lomb 27G Sterile Cannula Packed in Amvisc and Amvisc Plus Ophthalmic Viscosurgical Devices (OVD) because Cannulas May Leak or Detach From the Syringe.
Bausch and Lomb Inc. initiated the Bausch and Lomb recall of its Eye Surgery Solution because the cannulas may leak viscoelastic material or detach from the syringe during an injection, which the FDA warns can result in serious injury to the patient. Bausch and Lomb advised customers to discontinue the use and either destroy or quarantine the product recall under refrigeration until a Sales Representative visit to your site
FDA Issues Class 1 Safety Alert Notice for Bausch and Lomb Recall
According to the Bausch and Lomb recall notice, serious injuries have been reported in connection with the 27G disposable cannulas that are provided with the Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD). The OVD is a sterile gel that is packed in a disposable glass syringe with water-retention properties. The 27G cannula is attached to a syringe by a standard fitting and is used during procedures such as cataract surgery, as a surgical aid to the front part of the eye, or behind the iris.
Products Included In Bausch and Lomb Recall
Bausch and Lomb 27G sterile cannula packed in Bausch and Lomb:
- Amvisc 1.2% Sodium Hyaluronate (Model 59051, 59081, 59051L, 59081L)
- Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device.
Lot numbers included in the recall are:
B100003G, B100015A, B100015D, B100023A, B100023B, B100023C, B100023D, B100023E, B100039D, B100039F, B100046A, B100046B, B100046C, B100058A, B100069A, B110027D, B110028C, B110048A, B110048D, B110056A, B12,0011D, B120016A, D100008B, D100009A, D100011A, D100011B, D100011C, D100016B, D100016C, D100022A, D100022B, D100022C, D100022D, D100026A, D100026C, D100026D, D100026E, D100030A, D100030B, D100030C, D100035A, D100035C, D100035D, D100043A, D100043B, D100043C, D100044B, D100044C, D100044D, D100044E, D100045A, D100045B, D100045C, D100059A, D100059B, D100059C, D100060A, D100060B, D100061A, D100061B, D100080A, D100081A, D100081AS, D110015A, D110015B, D110016A, D110045A, D110046A, D110047A, D110070A, D110071A, D110072A, D110090A, D110090B, D110091A, D110092A, D110108A, D110108B, D110108BR, D120015A, D120015B, D120027A, D120028A, D120029A, D120029B, D120038B, D120039A, D120068A, D120068B, 023632, 023633, 023639, 023640, 023647, 023801, 023811, 023863, 023886, 023897, 023920, 023933, 023972, 024022, 024025, 024028, 024257, 024323, 024436, C10003B, E090105A, D090095B, D090096A, D090096C, D090097C, D090097D
According to the FDA, Bausch and Lomb began to notify customers of the Bausch and Lomb recall via telephone on November 14, 2012, and then began sending product recall letters on November 15, 2012. However, after serious adverse events were reported, including serious injury, the FDA issued a recall safety alert on January 23, 2013, warning the public of this Class 1 Recall.
Class 1 recalls are considered by the government agency to be the most serious type of recall because they involve situations where there is reasonable probability that use of the products could cause serious adverse health consequences or death.
What To Do
Consumers and healthcare professionals can report adverse events or any problems and issues they might have experienced directly to the FDA through the Adverse Event Reporting program online, or by fax or telephone. (https://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm)
Consumers who have question or concerns regarding the Bausch and Lomb recall can contact Bausch and Lomb at 585-388-8731
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