MW5078621
Report
- Report Number
- MW5078621
- Event Type
- Injury
- Date Received
- July 25, 2018
- Date of Event
- May 9, 2018
- Report Date
- June 22, 2018
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
DECREASED VISION IN RIGHT EYE AFTER HAVING YAG CAPSULOTOMY PERFORMED; MAYBE PERMANENT. PT RECEIVED A YAG CAPSULOTOMY IN THE RIGHT EYE AFTER CATARACT EXTRACTION; PROCEDURE PERFORMED BY A FELLOW PHYSICIAN ((B)(6)); NO PROBLEMS REPORTED DURING THE PROCEDURE. THE FOLLOWING DAY THE PT PRESENTED BACK TO THE CLINIC WITH COMPLAINTS OF DECREASED VISION AND A DIM SPOT IN CENTRAL VISION THAT HAD GOTTEN LARGER; UPON EXAMINATION IT WAS NOTED THAT HER VISION HAD DECREASED FROM NEAR 20/20 TO 20/200 IN THE RIGHT EYE; MACULAR EDEMA ALSO NOTED DURING THAT EXAM AND WAS DOCUMENTED WITH RETINAL PHOTOS AND A FLUORESCEIN ANGIOGRAPHY; EXAM INFO THEN RELAYED TO A RETINAL SPECIALIST FOR OPINION. HE RECOMMENDED SHE BE SEEN IN HIS CLINIC AT NEXT VISIT, BUT RECOMMENDED NO TREATMENT AT THAT TIME. AT THE RETINAL EXAM BY THE SPECIALIST ON (B)(6), IT WAS NOTED THAT THE EDEMA HAD IMPROVED BUT THE VISION HAD NOT. SPECIALIST COMMENTED THAT IT LOOKED SIMILAR TO BLUNT TRAUMA TO THE EYE (COMMOTIO RETINAE); COULD NOT RULE OUT THE YAG LASER AS NOT HAVING CAUSED EVENT. LASER IMMEDIATELY REMOVED FROM SERVICE AND MFR CALLED FOR SERVICE. INVESTIGATION STARTED AND CURRENTLY ONGOING. TRYING TO DETERMINE IF IT WAS USER ERROR OR A TECHNICAL ISSUE. MFR HAS BEEN CONTACTED TO OPEN, AN INVESTIGATION AS WELL AND REPORT TO FDA. DOSE OR AMOUNT: 1.4 MJ X 41, PULSES = 56.18 MJ. DATES OF USE: (B)(6) 2017 TO (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: POSTERIOR CAPSULAR OPACITY OD. "IS THE PRODUCT COMPOUNDED: NO; IS THE PRODUCT OVER-THE-COUNTER: NO."
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other| S |