FS DISPOSABLE INTERFACE 660065ANRecalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · 2 PROC PACK · Class 1
Quick summary
This Johnson & Johnson Surgical Vision FS Disposable Interface is a single-use suction ring used with an AC-powered keratome during eye surgery. Most reports describe the suction weakening or dropping out mid-procedure, sometimes while the laser was firing, so the procedure had to be finished with new suction rings; a few also mention contamination or scratched material. There are 65 reports, no deaths and 5 injuries. 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
- 65
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 05050474535305), received between Sep 15, 2016 and Jan 29, 2026 — classified as 5 injuries, 60 malfunctions.
The most frequently reported specific device problem is “Decrease in Suction” (32 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Decrease in Suction32
- Suction Problem30
- Use of Device Problem5
- Contamination3
- Device Contaminated During Manufacture or Shipping1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Consequences Or Impact To Patient29
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Eye Injury1
- No Code Available1
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2026Decrease in Suction
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24211246 ↗MalfunctionJan 20, 2026Decrease in Suction; Use of Device Problem
IT WAS REPORTED THAT A SUCTION LOSS DURING THE RASTER PATTERN OCCURRED WHILE USING THE PATIENT INTERFACE. THE PROCEDURES WERE COMPLETED BY USING NEW SUCTION RINGS. AFTER FURTHER REVIEW THE PRODUCT WAS USED EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. NOTE: THIS REPORT IS 4 OF 4 REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24117807 ↗MalfunctionJan 20, 2026Decrease in Suction; Use of Device Problem
IT WAS REPORTED THAT A SUCTION LOSS DURING THE RASTER PATTERN OCCURRED WHILE USING THE PATIENT INTERFACE. THE PROCEDURES WERE COMPLETED BY USING NEW SUCTION RINGS. AFTER FURTHER REVIEW THE PRODUCT WAS USED EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. NOTE: THIS REPORT IS 3 OF 4 REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24117695 ↗MalfunctionJan 20, 2026Decrease in Suction; Use of Device Problem
IT WAS REPORTED THAT A SUCTION LOSS DURING THE RASTER PATTERN OCCURRED WHILE USING THE PATIENT INTERFACE. THE PROCEDURES WERE COMPLETED BY USING NEW SUCTION RINGS. AFTER FURTHER REVIEW THE PRODUCT WAS USED EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. NOTE: THIS REPORT IS 2 OF 4 REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24117671 ↗MalfunctionJan 20, 2026Decrease in Suction; Use of Device Problem
IT WAS REPORTED THAT A SUCTION LOSS DURING THE RASTER PATTERN OCCURRED WHILE USING THE PATIENT INTERFACE. THE PROCEDURES WERE COMPLETED BY USING NEW SUCTION RINGS. AFTER FURTHER REVIEW THE PRODUCT WAS USED EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. NOTE: THIS REPORT IS 1 OF 4 REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24117642 ↗MalfunctionOct 31, 2025Decrease in Suction; Decrease in Suction
THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23443056 ↗MalfunctionJul 29, 2025Decrease in Suction; Decrease in Suction
THIS REPORT SUMMARIZES 74 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22649684 ↗MalfunctionJul 28, 2025Decrease in Suction; Decrease in Suction
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. THE EVENT WAS RELATED TO SUCTION LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22628423 ↗InjuryJun 19, 2025Use of Device Problem; Use of Device Problem
THE COMPLAINT PERTAINS TO AN INTRAOPERATIVE EVENT OF VERTICAL GAS BREAKTHROUGH REPORTED BY THE CUSTOMER. WHILE THE FIRST EYE WAS SUCCESSFULLY TREATED, THE FLAP ON THE SECOND EYE COULD NOT BE LIFTED DUE TO THE ESCAPE OF GAS BUBBLES. THE CERTIFIED SURGEON, OBSERVED THE GAS BREAKTHROUGH AND SOUGHT CLARIFICATION REGARDING THE APPROPRIATE TIMEFRAME FOR PERFORMING THE PHOTOREFRACTIVE KERATECTOMY (PRK) PROCEDURE ON THE AFFECTED EYE. OUR CLINICAL APPLICATION SPECIALIST (CAS) EXPLAINED THAT THERE IS NO SPECIFIC RECOMMENDATION FOR THE TIMEFRAME, LEAVING THE DECISION TO THE SURGEON'S DISCRETION, AND ADVISED AGAINST LIFTING THE FLAP IN SUCH SITUATIONS. NO INTRAOPERATIVE INTERVENTION NECESSARY. FLAP WAS NOT LIFTED. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS PRESCRIBED. CUSTOMER USED AN EXPIRED PATIENT INTERFACE ON THIS PROCEDURE. PATIENT OUTCOME AFTER THE PRK PROCEDURE WAS 20/30-2, WITH PIN HOLE 20/20+1 ON THE FIRST DAY FOLLOWING SURGERY. NOTE: THIS IS REPORT 2 OF 2.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Injury
MAUDE report 22290212 ↗MalfunctionJan 23, 2025Decrease in Suction; Decrease in Suction
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. THE EVENTS WERE RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21220036 ↗MalfunctionOct 22, 2024Decrease in Suction; Decrease in Suction
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20510947 ↗MalfunctionApr 24, 2024Decrease in Suction; Decrease in Suction
B5 - THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19176417 ↗MalfunctionMar 11, 2024Contamination; Contamination
IT WAS REPORTED THAT THERE WAS DEBRIS/FOREIGN MATTER ON THE PATIENT INTERFACE (PI) WHICH TOUCHED THE PATIENT'S EYE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY SWITCHING TO A DIFFERENT PI. NO PATIENT INJURY AND/OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18877388 ↗MalfunctionJan 25, 2024Decrease in Suction; Decrease in Suction
THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS. THE EVENT WAS RELATED TOSUCTION LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18582761 ↗MalfunctionNov 14, 2023Contamination; Decrease in Suction; Contamination; Decrease in Suction
IT WAS REPORTED THAT THERE WAS DEBRIS ON THE PATIENT INTERFACE (PI). THE PROCEDURE WAS COMPLETED WITH A NEW PI. NO PATIENT INJURY AND/OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18136097 ↗MalfunctionOct 30, 2023Decrease in Suction; Decrease in Suction
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18035311 ↗MalfunctionOct 30, 2023Decrease in Suction; Decrease in Suction
THIS REPORT SUMMARIZES 138 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18033176 ↗MalfunctionJul 29, 2023Decrease in Suction; Decrease in Suction
THIS REPORT SUMMARIZES 298 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS DURING LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17421437 ↗MalfunctionJul 28, 2023Decrease in Suction; Decrease in Suction
THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS DURING LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17421219 ↗MalfunctionApr 29, 2023Decrease in Suction; Decrease in Suction
THIS REPORT SUMMARIZES 265 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16841096 ↗MalfunctionApr 28, 2023Decrease in Suction; Decrease in Suction
THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS DURING LASER FIRE THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16834047 ↗MalfunctionJan 25, 2023Decrease in Suction; Decrease in Suction
THIS REPORT SUMMARIZES 11 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16241701 ↗MalfunctionOct 30, 2022Decrease in Suction; Decrease in Suction
THIS REPORT SUMMARIZES 240 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15697614 ↗MalfunctionOct 29, 2022Decrease in Suction; Decrease in Suction
THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15695649 ↗InjuryOct 21, 2022Decrease in Suction; Decrease in Suction
THE ACCOUNT REPORTED SUCTION LOSS AFTER THE LASER FIRED OCCURRED WITH A PATIENT INTERFACE. THE SURGERY WAS COMPLETED SUCCESSFULLY BY SWITCHING TO PHOTOREFRACTIVE KERATECTOMY (PRK). NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15654977 ↗
Other KERATOME, AC-POWERED devices
- FS DISPOSABLE INTERFACE 590106ANJohnson & Johnson Surgical Vision, Inc. · KERATOME, AC-POWERED4,174 reports
- FS LASER SYSTEM 20005DJohnson & Johnson Surgical Vision, Inc. · KERATOME, AC-POWERED883 reports
- IFS ADVANCED FEMTOSEC LASER J20007DJohnson & Johnson Surgical Vision, Inc. · KERATOME, AC-POWERED647 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.