OPHTHALMIC YAG LASER SYSTEM YC-1800Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04987669100073), received between Aug 31, 2017 and Dec 15, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (8 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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2021Unexpected Therapeutic Results; Unexpected Therapeutic Results

  PLEASE SEE INITIAL MDR SUBMITTED ON 12/15/2021.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13014645 ↗
• MalfunctionApr 29, 2021Unexpected Therapeutic Results; Insufficient Device Problem Information; Patient Device Interaction Problem; Unexpected Therapeutic Results; Insufficient Device Problem Information; Patient Device Interaction Problem

  PLEASE SEE THE INITIAL MDR SUBMITTED ON 29-APR-2021.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11748164 ↗
• MalfunctionNov 20, 2019Energy Output Problem; Energy Output Problem

  PLEASE SEE INITIAL MDR SUBMISSION ON (B)(6) 2019.

  Patient problems: Retinal Injury

  MAUDE report 9351336 ↗
• MalfunctionMay 16, 2019Energy Output Problem; Unexpected Therapeutic Results; Energy Output Problem; Unexpected Therapeutic Results

  PLEASE SEE THE INITIAL MDR SUBMITTED ON 16-MAY-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8618016 ↗
• MalfunctionMay 16, 2019Energy Output Problem; Unexpected Therapeutic Results; Energy Output Problem; Unexpected Therapeutic Results

  PLEASE SEE THE INITIAL MDR SUBMITTED ON 16-MAY-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8617969 ↗
• MalfunctionApr 10, 2018Unexpected Therapeutic Results; Unexpected Therapeutic Results; Device Operates Differently Than Expected

  ON CONCOMITANT MEDICAL PRODUCTS:2018, THE CUSTOMER CONTACTED NIDEK INC. FIELD SERVICE MANAGER WHO LATER COMMUNICATED TO NIDEK INC. CUSTOMER SERVICE MANAGER TO REPORT THAT THE DOCTOR OBSERVED PITTING LENS DURING SURGICAL PROCEDURE. A TOTAL OF 3 INCIDENTS WERE REPORTED AND A SEPARATE MDR WILL BE SUBMITTED FOR EACH CASE. TWO PATIENTS HAVE ACRYSOFT (B)(4) MONOFOCAL LENS AND ONE HAVE MULTIFOCAL LENS. THERE WAS NO SERIOUS ADVERSE EVENT REPORTED FROM THE USER FACILITY BUT NIDEK INC. CONSIDERS PITTING LENS ISSUE ON YC-1800 A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUE WERE TO RECUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7420020 ↗
• MalfunctionApr 10, 2018Unexpected Therapeutic Results; Unexpected Therapeutic Results; Device Operates Differently Than Expected

  ON (B)(6) 2018, THE CUSTOMER CONTACTED NIDEK INC. FIELD SERVICE MANAGER WHO LATER COMMUNICATED TO NIDEK INC. CUSTOMER SERVICE MANAGER TO REPORT THAT THE DOCTOR OBSERVED PITTING LENS DURING SURGICAL PROCEDURE. A TOTAL OF 3 INCIDENTS WERE REPORTED AND A SEPARATE MDR WILL BE SUBMITTED FOR EACH CASE. TWO PATIENTS HAVE ACRYSOFT SN60WF MONOFOCAL LENS AND ONE HAVE MULTIFOCAL LENS. THERE WAS NO SERIOUS ADVERSE EVENT REPORTED FROM THE USER FACILITY BUT NIDEK INC. CONSIDERS PITTING LENS ISSUE ON YC-1800 A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUE WERE TO RECUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7419968 ↗
• MalfunctionApr 10, 2018Unexpected Therapeutic Results; Unexpected Therapeutic Results; Device Operates Differently Than Expected

  ON (B)(6) 2018, NIDEK INC. CUSTOMER SERVICE MANAGER RECEIVED A PHONE CALL FROM A NIDEK INC. FIELD SERVICE MANAGER TO REPORT THAT A CUSTOMER (DOCTOR) WAS COMPLAINING THAT THE YAG LASER YC-1800 SERIAL (B)(4) EXPERIENCING PITTING LENSES DURING SURGERY. THERE WERE THREE PATIENTS INVOLVED DURING THE PROCEDURES, THEREBY, THREE INDIVIDUAL REPORTS WILL BE SUBMITTED. TWO PATIENTS SURGERIES WERE COMPLETED IN THE OFFICE WITHOUT ANY COMPLICATIONS AND ONE PATIENT HAD TO BE RESCHEDULED FOR LASER CAPSULOTOMY AT THE HOSPITAL AND THE SURGERY ALSO WAS COMPLETED WITHOUT ANY COMPLICATIONS. THERE WAS NO SERIOUS ADVERSE EVENTS REPORTED, PATIENTS INVOLVED DID NOT COMPLAIN OF ANY EYE COMPLICATIONS AFTER THE SURGERIES BUT NIDEK INC. CONSIDERS PITTING LENS ISSUE A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUE TO RECUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7419964 ↗
• MalfunctionAug 31, 2017Unexpected Therapeutic Results; Device Operates Differently Than Expected; Unexpected Therapeutic Results; Device Operates Differently Than Expected

  SEE INITIAL MDR 0002936921-2017-00022 FOR DETAILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6836698 ↗