Lutronic Clarity II laser system reported sparking and popping during use
Lutronic is recalling the CLARITY II Laser System after reports of devices sparking or popping and potentially burning patients.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the source records reports of sparking and popping and describes burns as potential rather than confirmed.
Plain-English summary
Lutronic Corporation is recalling the CLARITY II Laser System, model 1110200210. About 1,525 units were distributed worldwide, covering the United States nationwide and Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, the Philippines, Taiwan and Thailand. The FDA has classified this recall as Class II.
There have been reports of devices sparking or popping and potentially burning patients.
Affected product carries UDI 08809447653723, across a long list of serial numbers beginning C3019J018.
Facilities can identify affected systems by the model number, UDI and serial numbers above, and may contact Lutronic Corporation for further information.
The recalled product
- Product
- CLARITY II Laser System; Model No. 1110200210.
- Manufacturer
- Lutronic Corporation
- Category
- Medical Device — Laser system
- Affected units
- 1,525
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 (20)
- Model No. 1110200210
- UDI: 08809447653723
- Serial No. C3023K024
- C3022B006
- C3025D028
- C3022L031
- C3024D027
- C3022H015
- C3024K033
- C3019J018
- C3024K030
- C3025B076
- C3023K043
- C3021K002
- C3025E050
- C3025E035
- C3022L010
- C3023G009
- C3023J037
- C3021D021
Distribution
Distributed nationwide across the United States.
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