WaveLight 8065998298Recalls & reported problems
Alcon Laboratories, Inc. · WAVELIGHT FS200 PATIENT INTERFACE - EASYPACK (BOX OF 20) · Class 2
All models of WaveLight (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon WaveLight patient interface, a disposable suction pack used with a powered laser eye surgery system, is the subject of 38 adverse event reports. The reports mostly describe the suction weakening or stopping partway through a procedure, with one noting suction was lost into the treatment before the laser fired. No deaths or injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00380659982989), received between Sep 9, 2021 and May 15, 2023 — classified as 38 malfunctions.
The most frequently reported specific device problem is “Decrease in Suction” (34 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Decrease in Suction34
- Suction Failure4
Patient problems
- Insufficient Information33
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2023Decrease in Suction; Decrease in Suction
NEW INFORMATION WAS RECEIVED. EVENT OCCURRED BEFORE LASER FIRED. HENCE, NOT QUALIFIED FOR THE REPORTABLE EVENT.
Patient problems: Insufficient Information
MAUDE report 16935860 ↗MalfunctionFeb 1, 2023Decrease in Suction; Decrease in Suction
A HEALTHCARE PROFESSIONAL REPORTED SUCTION WAS LOST INTO THE TREATMENT. CUSTOMER HAD PROBLEM WITH SUCTION. NEW PATIENT INTERFACE WAS COMPLETED THE FLAP PROCEDURE WITH NO ISSUES.
Patient problems: Insufficient Information
MAUDE report 16276156 ↗MalfunctionJan 10, 2023Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE REPORTED LOSS OF SUCTION WITH ONE PATIENT INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PI (B)(4) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16130149 ↗MalfunctionJan 10, 2023Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE REPORTED LOSS OF SUCTION WITH ONE PATIENT INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PATIENT INTERFACE (PI) (B)(4) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16130116 ↗MalfunctionJan 10, 2023Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE REPORTED LOSS OF SUCTION WITH ONE PATIENT INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PI (B)(4). AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16129963 ↗MalfunctionDec 29, 2022Suction Failure; Suction Failure
A FACILITY REPRESENTATIVE REPORTED FAILED SUCTION WITH ONE PATIENT INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PATIENT INTERFACE (PI) (B)(4) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 16067486 ↗MalfunctionDec 29, 2022Suction Failure; Suction Failure
A FACILITY REPRESENTATIVE REPORTED FAILED SUCTION WITH ONE PATIENT INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PATIENT INTERFACE (PI) (B)(4) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 16067484 ↗MalfunctionDec 28, 2022Suction Failure; Suction Failure
A FACILITY REPRESENTATIVE REPORTED FAILED SUCTION WITH ONE PATIENT INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PATIENT INTERFACE (PI) (B)(4) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 16062280 ↗MalfunctionDec 28, 2022Suction Failure; Suction Failure
A FACILITY REPRESENTATIVE REPORTED FAILED SUCTION WITH ONE PATIENT INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PATIENT INTERFACE (PI) ((B)(4)) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 16062265 ↗MalfunctionSep 28, 2022Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE REPORTED SUCTION WAS LOST WITH ONE PATIENT INTERFACE.
Patient problems: Insufficient Information
MAUDE report 15495659 ↗MalfunctionSep 24, 2022Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE REPORTED SUCTION WAS LOST WITH ONE PATIENT INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PI (B)(4) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 15475803 ↗MalfunctionSep 24, 2022Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE SUCTION LOSS WITH ONE PATIENT INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PI (8470010001072996) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 15475762 ↗MalfunctionJul 21, 2022Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE REPORTED A PATIENT WITH SUCTION WAS LOST AT THE POINT OF CANAL CREATION IN THE RIGHT EYE DURING LASIK SURGERY. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PI (B)(4), AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 15078364 ↗MalfunctionJul 18, 2022Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE A PATIENT WITH LOSS OF SUCTION WITH ONE INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PI (B)(4) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 15043025 ↗MalfunctionJul 18, 2022Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE A PATIENT WITH LOSS OF SUCTION WITH ONE INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PI (B)(4) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 15043022 ↗MalfunctionJul 18, 2022Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE A PATIENT WITH LOSS OF SUCTION WITH ONE INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PI (B)(4) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 15042923 ↗MalfunctionJul 18, 2022Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE A PATIENT WITH LOSS OF SUCTION WITH ONE INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PI (B)(4) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 15042916 ↗MalfunctionJul 18, 2022Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE A PATIENT WITH LOSS OF SUCTION WITH ONE INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PI (B)(4) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 15042912 ↗MalfunctionJul 18, 2022Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE A PATIENT WITH LOSS OF SUCTION WITH ONE INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PI (B)(4) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 15042878 ↗MalfunctionJul 18, 2022Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE A PATIENT WITH LOSS OF SUCTION WITH ONE INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PI (B)(4) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 15042814 ↗MalfunctionJul 18, 2022Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE A PATIENT WITH LOSS OF SUCTION WITH ONE INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PI (B)(4) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 15042761 ↗MalfunctionJul 18, 2022Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE A PATIENT WITH LOSS OF SUCTION WITH ONE INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PI (B)(4) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 15042746 ↗MalfunctionJul 18, 2022Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE REPORTED A PATIENT WITH LOSS OF SUCTION WITH ONE INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES A PI (B)(6) AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 15042710 ↗MalfunctionJun 2, 2022Decrease in Suction; Decrease in Suction
A FACILITY REPRESENTATIVE REPORTED SUCTION WAS LOST IN MIDDLE OF THE TREATMENT WITH ONE PATIENT INTERFACE.
Patient problems: Insufficient Information
MAUDE report 14571864 ↗MalfunctionMay 7, 2022Decrease in Suction; Decrease in Suction
A HEALTH CARE PROFESSIONAL REPORTED SUCTION WAS LOST WITH A PATIENT INTERFACE.
Patient problems: Insufficient Information
MAUDE report 14314742 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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