Recall Z-1515-2015— Abbott Medical Optics, Inc.
Class II · Terminated
Class II FDA medical device recall by Abbott Medical Optics, Inc., initiated 2015-02-20, terminated 2019-07-09. It names one FDA 510(k) clearance: K141079. Product: OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.. Reason: Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation..
- Recalling firm
- Abbott Medical Optics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-20
- Terminated
- 2019-07-09
- Firm location
- Milpitas, 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
OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
Reason for recall
Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.