Ophthalmic YAG Laser System YC-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04987669101452), received between Jun 3, 2021 and May 20, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON (B)(6) 2022, NIDEK INC. SERVICE MANAGER RECEIVED A TELEPHONE CALL FROM NIDEK INC SALES REPRESENTATIVE TO REPORT THAT THE CUSTOMER REPORTED PITTING LENS. A FOLLOWUP WAS DONE BY NIDEK INC SERVICE MANAGER TO SPEAK WITH THE DOCTOR AND CONFIRMED THAT SHE HAS BEEN HAVING SOME ISSUES WITH PITTING LENS, NO INJURY REPORTED. THE DEVICE EVALUATION WAS COMPLETED AT THE CUSTOMER SITE ON (B)(6) 2022 PER CUSTOMER SERVICE ORDER #(B)(4) BY NIDEK INC FIELD SERVICE ENGINEER. NIDEK INC. CONSIDERS PITTING LENS ISSUE A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUE WERE TO RECUR. DURING THE VISIT, CUSTOMER INFORMED FSE FOLLOWING: ON (B)(6) 2022, LENS PITTED 4 TIMES WITH 24 SHOTS EMITTED WITH A SETTING OF 1.3MJ POWER OUTPUT AND 250 POSTERIOR. ON (B)(6) 2022, LENS PITTED ONCE WITH 48 SHOTS EMITTED WITH A SETTING OF 1.0MJ POWER OUTPUT AND 275 POSTERIOR. MODE: SINGLE. MAGNIFICATION: 20X. TOTAL SHOT COUNT: 7544. DATE OF MANUFACTURE OF YC-200 S PLUS S/N. (B)(4): (B)(6) 2021. TECHNICAL BACKGROUND: THE OPHTHALMIC YAG LASER SYSTEM YC-200 CONSISTS OF A SLIT LAMP AND THE YAG LASER AND IS INDICATED FOR THE PERFORMANCE OF POSTERIOR

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

  MAUDE report 14459584 ↗
• MalfunctionMay 20, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  NIDEK INC RECEIVED A TELEPHONE CALL FROM THE CUSTOMER TO REPORT THAT THEY OBSERVED PITTING LENS WHEN FIRED THE LASER FOR THE FIRST TIME. FOCUS SHIFT SETTING WAS 250 POSTERIOR. THE PITTING LENS HAPPEN LAST WEEK, AND THE DOCTOR INFORMED THE TECHNICIAN AT THE CUSTOMER SITE TO REPORT PITTING LENS TO NIDEK INC ON (B)(6) 2022, AND NIDEK INC RECEIVED A TELEPHONE CALL ON 05/09/2022. NO INJURY WAS REPORTED FROM THE CUSTOMER. DEVICE EVALUATION IS PENDING. NIDEK INC. CONSIDERS PITTING LENS ISSUE A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUE WERE TO RECUR. TECHNICAL BACKGROUND: THE OPHTHALMIC YAG LASER SYSTEM YC-200 CONSISTS OF A SLIT LAMP AND THE YAG LASER AND IS INDICATED FOR THE PERFORMANCE OF POSTERIOR CAPSULOTOMY, PUPILLARY MEMBRANECTOMY, IRIDOTOMY (HOLE IN THE IRIS) AND SELECTIVE LASER TRABECULOPLASTY. THIS DEVICE USES PASSIVE Q-SWITCHING FOR LASER OSCILLATION. WITH PASSIVE Q-SWITCHING, THE DEVICE FIRST ACCUMULATES SUFFICIENT ENERGY WITHIN THE LASER CAVITY THEN EMITS LASER PULSES OF HIGH PEAK POWER FOR EXTREMELY SHORT DURATIONS BY USE OF THE Q-SWITCHED OPTICAL ELEMENT WHICH CHANGES BETWEEN TRANSPARENT AN

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

  MAUDE report 14459549 ↗
• MalfunctionMay 4, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON (B)(6) 2022. NIDEK INC. CUSTOMER SERVICE REPRESENTATIVE RECEIVED AN EMAIL FROM THE CUSTOMER TO REPORT THAT ONE DOCTOR IS PITTING LENS, HE IS USING 1.2MJ AND A 275UM OFFSET, LOW ENERGY, LARGE OFFSET, NO ERROR DISPLAY ON UNIT. NO INJURY REPORTED. ON (B)(6) 2022. THE DEVICE EVALUATION WAS COMPLETED AT THE CUSTOMER SITE ON 04/13/2022. PER CUSTOMER SERVICE ORDER #CSO-2022-0278 BY NIDEK INC FIELD SERVICE ENGINEER. NIDEK INC. CONSIDERS PITTING LENS ISSUE A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUE WERE TO RECUR. TECHNICAL BACKGROUND: THE OPHTHALMIC YAG LASER SYSTEM YC-200 CONSISTS OF A SLIT LAMP AND THE YAG LASER AND IS INDICATED FOR THE PERFORMANCE OF POSTERIOR CAPSULOTOMY, PUPILLARY MEMBRANECTOMY, IRIDOTOMY (HOLE IN THE IRIS) AND SELECTIVE LASER TRABECULOPLASTY. THIS DEVICE USES PASSIVE Q-SWITCHING FOR LASER OSCILLATION. WITH PASSIVE Q-SWITCHING, THE DEVICE FIRST ACCUMULATES SUFFICIENT ENERGY WITHIN THE LASER CAVITY THEN EMITS LASER PULSES OF HIGH PEAK POWER FOR EXTREMELY SHORT DURATIONS BY USE OF THE Q-SWITCHED OPTICAL ELEMENT WHICH CHANGES BETWEEN TRANSPARENT AND OPAQUE ACCORDING TO THE ACCUMULAT

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

  MAUDE report 14283301 ↗
• MalfunctionFeb 16, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON (B)(6) 2022, NIDEK INC. SALES MANAGER RECEIVED AN EMAIL FROM A DOCTOR REPORTING THAT HE HAS PITTED THE LENS ON ALL 7 YAG CAPS HE HAS DONE SO FAR WITH YC-200S S/N (B)(4) . PER DOCTOR, "ALL TURNED OUT SUBJECTIVELY AS EXPECTED WITH HAPPY PATIENT OUTCOMES. REMARKABLE IOP REDUCTION ON SLT." PER DOCTOR, THE PITTING LENSES HAVE OCCURRED ON THE FOLLOWING DATES: (B)(6) 2021, (B)(6) 2021, AND (B)(6) 2022. NIDEK INC. CONSIDERS PITTING LENS ISSUE A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS A POTENTIAL CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUES WERE TO RECUR. TECHNICAL BACKGROUND: THE OPHTHALMIC YAG LASER SYSTEM YC-200/ YC-200 S PLUS CONSISTS OF A SLIT LAMP AND THE YAG LASER AND IS INDICATED FOR THE PERFORMANCE OF POSTERIOR CAPSULOTOMY, PUPILLARY MEMBRANECTOMY, IRIDOTOMY (HOLE IN THE IRIS) AND SELECTIVE LASER TRABECULOPLASTY. THIS DEVICE USES PASSIVE Q-SWITCHING FOR LASER OSCILLATION. WITH PASSIVE Q-SWITCHING, THE DEVICE FIRST ACCUMULATES SUFFICIENT ENERGY WITHIN THE LASER CAVITY THEN EMITS LASER PULSES OF HIGH PEAK POWER FOR EXTREMELY SHORT DURATIONS BY USE OF THE Q-SWITCHED OPTICAL ELEMENT WHICH CHANGES BETWEEN TRANSPARENT AND OPAQUE ACCORDING TO THE ACCUMULATIO

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

  MAUDE report 13546068 ↗
• MalfunctionJan 11, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON DECEMBER 17, 2021. NIDEK INC CUSTOMER SERVICE REPRESENTATIVE RECEIVED AN EMAIL FROM THE CUSTOMER TO REPORT THAT THE DOCTORS NOTICED SOME PITTING ON THE IOL DURING CAPSULOTOMY PROCEDURES. THE ISSUE OCCURRED WHILE USING YC-200 S PLUS YAG LASER (B)(4) IN THE FACILITY'S LASER ROOM. FOLLOW UPS WERE MADE TO THE CUSTOMER BY RA/QA DIRECTOR AND FIELD SERVICE MANAGER BETWEEN THE DATES OF 12/17-12/23/2021; NO RESPONSE RECEIVED TO CONFIRM THE DATE OF OCCURRENCE. NO INJURY TO PATIENTS WAS REPORTED. LASER WAS INSPECTED/SERVICED IN THE FIELD AT THE CUSTOMER'S OFFICE PER NIDEK REFERENCE# (B)(4).

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

  MAUDE report 13231239 ↗
• MalfunctionSep 13, 2021Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON (B)(6) 2021, NIDEK INC CUSTOMER REPRESENTATIVE RECEIVED AN EMAIL FROM THE CUSTOMER TO REPORT THAT THE DOCTOR SAW PITTING ON IOL BUT PUSHED THE LASER FORWARD TO STOP IT FROM HAPPENING. THE DOCTOR REPORTS THAT IF FOCUSED BEHIND THE CAPSULE WITH THE AIMING BEAMS SPLIT, IT DOES FINE. THE DOCTOR INFORMED NIDEK INC THAT THE PATIENT IS FINE, PITTING WAS INFERIOR TO UNDILATED PUPIL AND WILL NOT INTERFERE WITH VISION. PATIENT WILL NOT HAVE ANY ADVERSE EFFECTS. NIDEK INC CONSIDERS THIS ISSUE ON YC-200 AS A REPORTABLE EVENT AS AN UNDESIRABLE CONDITION OCCURRED WHILE USING THE DEVICE. TECHNICAL BACKGROUND: THE OPHTHALMIC YAG LASER SYSTEM YC-200 CONSISTS OF A SLIT LAMP AND THE YAG LASER AND IS INDICATED FOR THE PERFORMANCE OF POSTERIOR CAPSULOTOMY, PUPILLARY MEMBRANECTOMY, IRIDOTOMY (HOLE IN THE IRIS) AND SELECTIVE LASER TRABECULOPLASTY. THIS DEVICE USES PASSIVE Q-SWITCHING FOR LASER OSCILLATION. WITH PASSIVE Q-SWITCHING, THE DEVICE FIRST ACCUMULATES SUFFICIENT ENERGY WITHIN THE LASER CAVITY THEN EMITS LASER PULSES OF HIGH PEAK POWER FOR EXTREMELY SHORT DURATIONS BY USE OF THE Q-SWITCHED OPTICAL ELEMENT WHICH CHANGES BETWEEN TRANSPARENT AND OPAQUE ACCORDING TO THE ACCUMULATION OF ENERGY.

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

  MAUDE report 12465408 ↗
• MalfunctionJun 3, 2021Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON (B)(6) 2021, NIDEK INC CUSTOMER SERVICE REPRESENTATIVE RECEIVED A TELEPHONE CALL FROM THE CUSTOMER TO REPORT THAT THE LASER IS TAKING MORE SHOTS TO GET AN OPENING, AND ALSO REPORTING THAT THE DOCTOR IS PITTING THE IOL. THE ISSUE OCCURRED WHILE USING THE YC-200 S PLUS DEVICE S/N. (B)(4) IN THE FACILITY'S LASER ROOM. ACCORDING TO THE DOCTOR: "WHEN WE DO YAG LASERS, WE FOCUS THE BEAM JUST A BIT POSTERIOR TO THE IOL. IF THE ENERGY HITS THE LENS DIRECTLY, IT WILL PIT IT. IT HAS MINIMAL IF ANY IMPACT ON THE PATIENTS VISION AND NOTHING IS DONE OR NEEDS TO BE DONE.". 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 ISSUES WERE TO RECUR.

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

  MAUDE report 11935696 ↗