14 results
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33ms
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Sources: EU EUDAMED, US FDA
TECNIS IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·April 18, 2025
NONE
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·March 8, 2022
DA VINCI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·February 25, 2022
DA VINCI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·February 25, 2022
DA VINCI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·February 25, 2022
NONE
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·March 8, 2022
NONE
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code GCJ·February 26, 2022
DA VINCI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·February 23, 2022
OPTICA FUKUI, INC.
FDA registration
OPTICA FUKUI, INC.·9 products·🇯🇵 Japan
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·July 16, 2025
G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).
FDA Recall
Terminated
·Interventional Spine Inc·Product code MAX·November 22, 2016
TECNIS SIMPLICITY
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·March 28, 2023
TECNIS SIMPLICITY
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·April 25, 2025
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices