TRUE METRIX TRUE METRIX Control Solution Level 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00021292008390), received between Aug 16, 2021 and Aug 5, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR THE TRUE METRIX LEVEL ONE CONTROL SOLUTION. SON IS CALLING ON BEHALF OF THE CUSTOMER. SON STATED THAT HE HAD ADMINISTERED ONE DROP OF CONTROL SOLUTION INTO EACH OF THE CUSTOMER'S EYES. CUSTOMER CURRENTLY HAD SOME REDNESS IN BOTH OF HER EYES. NO MEDICAL ATTENTION WAS REPORTED. THE CONTROL SOLUTION IS EXPIRED: MANUFACTURER¿S EXPIRATION DATE IS 02/28/2021.

  Patient problems: Red Eye(s)

  MAUDE report 15178512 ↗
• InjuryFeb 25, 2022Use of Device Problem; Use of Device Problem

  CONSUMER REPORTED THAT SHE HAD PUT ONE DROP OF TRUE METRIX CONTROL SOLUTION IN EACH OF HER EYES: CONTROL LEVEL ONE, LOT # 1BC1B44, MANUFACTURER¿S EXPIRATION DATE IS 12/31/2022. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER USES EYE DROPS AT NIGHT AND HAD USED THE CONTROL SOLUTION THE NIGHT BEFORE THINKING IT WAS THE EYE DROPS. CUSTOMER HAD WOKE UP THAT MORNING AND THE SKIN AROUND HER EYES WAS RED; CUSTOMER STATED THAT THE EYES WERE NOT RED, IT WAS THE SKIN AROUND THE EYES. CUSTOMER STATED SHE HAD NOT RINSED HER EYES. CUSTOMER STATED THAT SHE WAS NOT EXPERIENCING ANY PAIN IN HER EYES. CUSTOMER STATED SHE WAS GOING TO CONTACT THE EYE DOCTOR.

  Patient problems: Erythema

  MAUDE report 13603433 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED THAT SHE HAD PUT ONE DROP OF TRUE METRIX CONTROL SOLUTION IN HER EYE; CONTROL LEVEL ONE, LOT # 1BC1B46, MANUFACTURER¿S EXPIRATION DATE IS 03/31/2023. PHARMACIST IS CALLING ON BEHALF OF THE CUSTOMER THEN CONFERENCE THE CUSTOMER ON THE LINE. AT THE TIME OF THE CALL THE CUSTOMER WAS NOT EXPERIENCING ANY SYMPTOMS AS A RESULT; CUSTOMER HAD CONTACTED THE PHARMACIST WHO ADVISED CUSTOMER TO RINSE HER EYE WITH WATER USE ARTIFICIAL TEARS. CUSTOMER STATED SHE WAS GOING TO CONTACT HER DOCTOR.

  Patient problems: Insufficient Information

  MAUDE report 12324709 ↗