YC-1800
Received Jun 29, 2020 · Event occurred May 29, 2020
Report 0002936921-2020-00002 · MDR key 10209547
Device
Generic name
Yag Laser
Manufacturer
Nidek Inc.Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
NIDEK INC. SERVICE MANAGER RECEIVED AN EMAIL FROM A DOCTOR ON (B)(6) 2020 TO REPORT AN ADVERSE EVENT WITH THE NIDEK YAG LASER. THE DOCTOR HAD A PATIENT ON THE WEEK OF (B)(6) 2020 WHERE THE YAG LASER WAS USED FOR CAPSULOTOMY. ACCORDING TO THE DOCTOR, THE FOCUS WAS CORRECT, HOWEVER THE LASER FIRED MORE ANTERIORLY THAN THE FOCUSING LASER RESULTING IN IOL PITTING. NIDEK INC. SERVICE MANAGER CONTACTED THE CUSTOMER REGARDING ADDITIONAL PATIENT INFORMATION AND THE REPORTED PROBLEM ON (B)(6) 2020, (B)(6) 2020, (B)(6) /2020, HOWEVER; NO RESPONSE FROM THE DOCTOR WAS PROVIDED. SINCE NIDEK INC IS UNABLE TO OBTAIN THE DEVICE FOR ANALYSIS, FURTHER INVESTIGATION CANNOT BE PERFORMED.
Description of Event or Problem
NIDEK INC. SERVICE MANAGER RECEIVED AN EMAIL FROM A DOCTOR ON (B)(6) 2020 TO REPORT AN ADVERSE EVENT WITH THE NIDEK YAG LASER. THE DOCTOR HAD A PATIENT ON THE WEEK OF (B)(6) 2020 WHERE THE YAG LASER WAS USED FOR CAPSULOTOMY. ACCORDING TO THE DOCTOR, THE FOCUS WAS CORRECT, HOWEVER THE LASER FIRED MORE ANTERIORLY THAN THE FOCUSING LASER RESULTING IN IOL PITTING. NIDEK INC. SERVICE MANAGER CONTACTED THE CUSTOMER REGARDING ADDITIONAL PATIENT INFORMATION AND THE REPORTED PROBLEM ON (B)(6) 2020, (B)(6) 2020, (B)(6) 2020, HOWEVER; NO RESPONSE FROM THE DOCTOR WAS PROVIDED. SINCE NIDEK INC IS UNABLE TO OBTAIN THE DEVICE FOR ANALYSIS, FURTHER INVESTIGATION CANNOT BE PERFORMED.