Lumenis Array LaserLink Recall for Erroneous Retinal Pattern Display
Lumenis is recalling 16 Array LaserLink laser system accessories because they may project an incorrect pattern on the retina during treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a medical device used for ocular surgery where a defect could lead to unintended treatment patterns, representing a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Lumenis, Inc. has initiated a field correction for the Array LaserLink, a laser system accessory used for the treatment of ocular pathology. The device is indicated for various retinal and anterior segment procedures, including retinal photocoagulation and iridotomy.
The recall is due to a defect where the system may project an erroneous pattern display on the retina that differs from the desired pattern. This issue affects all assembled units since product release, identified by Part Number GA-0006700.
A total of 16 units are affected. These devices were distributed nationwide in the United States and internationally to Japan, China, and Canada. Healthcare providers should contact Lumenis for instructions on how to correct the field issue.
The recalled product
- Product
- Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal…
- Manufacturer
- Lumenis, Inc.
- Hazard
- Affected units
- 16
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)
- All assembled units since product release
- Part Number: GA-0006700.
Distribution
Distributed nationwide across the United States.
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