Recall Z-0649-2014— Optimedica Corporation
Class II · Terminated
Class II FDA medical device recall by Optimedica Corporation, initiated 2013-12-20, terminated 2014-06-26. It names one FDA 510(k) clearance: K121091. Product: Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.. Reason: Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke..
- Recalling firm
- Optimedica Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-20
- Terminated
- 2014-06-26
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
Reason for recall
Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke.
Data sourced from openFDA. This site is unofficial and independent of the FDA.