TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BEAVER-VISITEC INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BELKIN VISION, LTD.
	SUBSTANTIALLY EQUIVALENT	2
CARL ZEISS MEDITEC
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC, AG
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
ELLEX MEDICAL PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	2
EYEQ, INC.
	SUBSTANTIALLY EQUIVALENT	1
IRIDEX CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
LUMENIS BE, INC.
	SUBSTANTIALLY EQUIVALENT	1
LUTRONIC VISION, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIDIAN AG
	SUBSTANTIALLY EQUIVALENT	2
NORLASE
	SUBSTANTIALLY EQUIVALENT	1
NORLASE APS
	SUBSTANTIALLY EQUIVALENT	1
OD-OS GMBH
	SUBSTANTIALLY EQUIVALENT	1
QUANTEL MEDICAL
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Energy Output Problem	188	188
Failure to Fire	75	75
Adverse Event Without Identified Device or Use Problem	65	65
Appropriate Device Problem Term/Code Not Available	40	40
Failure to Deliver Energy	28	28
Unexpected Shutdown	13	13
Unexpected Therapeutic Results	9	9
Use of Device Problem	9	9
Intermittent Energy Output	9	9
Loss of Power	8	8
Insufficient Device Problem Information	7	7
No Display/Image	6	6
Firing Problem	6	6
Display or Visual Feedback Problem	5	5
Improper or Incorrect Procedure or Method	4	4
Self-Activation or Keying	3	3
Misfocusing	3	3
Device Operational Issue	3	3
Defective Component	3	3
Power Problem	2	2
Device Handling Problem	2	2
Noise, Audible	2	2
Audible Prompt/Feedback Problem	2	2
Break	2	2
Incomplete or Inadequate Connection	2	2
Device Misassembled During Manufacturing /Shipping	1	1
Device Contamination with Chemical or Other Material	1	1
Inappropriate or Unexpected Reset	1	1
Connection Problem	1	1
Operating System Becomes Nonfunctional	1	1
Output below Specifications	1	1
Application Program Problem	1	1
Patient-Device Incompatibility	1	1
Component Misassembled	1	1
Image Display Error/Artifact	1	1
Device Fell	1	1
Intermittent Loss of Power	1	1
Energy Spectrum Incorrect	1	1
Mechanical Problem	1	1
Misfire	1	1
Failure to Align	1	1
Output above Specifications	1	1
Failure to Power Up	1	1
Off-Label Use	1	1
Product Quality Problem	1	1
No Audible Prompt/Feedback	1	1
Program or Algorithm Execution Problem	1	1
Key or Button Unresponsive/not Working	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	251	251
Insufficient Information	122	122
Eye Burn	40	40
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	21	21
Intraocular Pressure Increased	16	16
Eye Injury	15	15
Uveitis	14	14
Visual Impairment	11	11
Blurred Vision	10	10
Eye Pain	10	10
Inflammation	10	10
Superficial (First Degree) Burn	6	6
Loss of Vision	5	5
Eye Irritation	5	5
Hemorrhage/Blood Loss/Bleeding	5	5
Corneal Edema	4	4
Unspecified Eye / Vision Problem	4	4
Iritis	3	3
Vitreous Hemorrhage	3	3
Vitreous Floaters	2	2
Pain	2	2
Intraocular Pressure Decreased	2	2
Electric Shock	2	2
Burn(s)	2	2
Visual Disturbances	2	2
Posterior Capsule Opacification	2	2
Pigment Dispersion Syndrome	2	2
Cataract	2	2
Corneal Clouding/Hazing	2	2
Retinal Degeneration	2	2
Conjunctivitis	1	1
Hyperemia	1	1
Diplopia/Double Vision	1	1
Hypopyon	1	1
Swelling/ Edema	1	1
Corneal Abrasion	1	1
Eye Infections	1	1
Scar Tissue	1	1
Dry Eye(s)	1	1
Red Eye(s)	1	1
Headache	1	1
Burning Sensation	1	1
Hypersensitivity/Allergic reaction	1	1
Convulsion/Seizure	1	1
Perforation	1	1
Halo	1	1
Retinal Injury	1	1
Fibrosis	1	1
Unspecified Infection	1	1
Adhesion(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Beaver-Visitec International, Inc.	II	Dec-31-2025
2	Dutch Ophthalmic USA, Inc.	II	Jul-20-2021
3	Ellex Medical Pty Ltd.	II	Jun-27-2023