MISIGHT 1 DAY (OMAFILCON A)
Report
- Report Number
- 3003981983-2025-00005
- Event Type
- Injury
- Date Received
- October 1, 2025
- Report Date
- October 8, 2025
- Manufacturer
- COOPERVISION MANUFACTURING, LTD
- Product Code
- QIT
- PMA / PMN Number
- P180035
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NO DEVICE SAMPLE RETURNED FOR MANUFACTURER ANALYSIS AND NO LOT NUMBER REPORTED, NO MANUFACTURERS INVESTIGATION COULD BE COMPLETED. GIVEN THE LACK OF AVAILABLE EVENT AND DEVICE DETAILS, NO ROOT CAUSE ESTABLISHED. NO RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT CAN BE CONFIRMED.
NEW RELEVANT MEDICAL INFORMATION RECEIVED FROM THE CONTACT LENS PRESCRIBING OPTICIAN, REPORT HAS BEEN UPDATED TO REFLECT ADDITIONAL DETAILS OF THE EVENT. REFER TO FIELDS (B5) AND (H6(E)) NO DEVICE SAMPLE RETURNED FOR MANUFACTURER ANALYSIS AND NO LOT NUMBER REPORTED, NO MANUFACTURERS INVESTIGATION COULD BE COMPLETED. GIVEN THE LACK OF AVAILABLE EVENT AND DEVICE DETAILS, NO ROOT CAUSE ESTABLISHED. NO RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT CAN BE CONFIRMED.
THIS INCIDENT WAS REPORTED TO THE MANUFACTURER BY THE CONTACT LENS PRESCRIBING OPTICIAN AS REPORTED TO THEM BY THE PATIENT. IT IS REPORTED THAT THE PATIENT IS A LONGTIME CONTACT LENS WEARER OF THIS SAME DEVICE. THE PATIENT WAS SEEN FOR A ROUTINE EYE APPOINTMENT AND REPORTED TO THE OPTICIAN AN INCIDENT WHICH OCCURRED APPROXIMATELY 10 WEEKS PRIOR. THE PATIENT WAS SEEN AT AN UNSPECIFIED HOSPITAL EYE SERVICES (HES) FOR AN UNSPECIFIED EYE INFECTION IN THE LEFT (OS) EYE. THE OPTICIAN IDENTIFIED 15 SCARS PRESENT DURING EXAM. DIAGNOSIS BY HES WAS NOT REPORTED, THE OPTICIAN SUSPECTS INFILTRATIVE KERATITIS BUT THIS HAS NOT BEEN CONFIRMED. PATIENT HAS RESUMED LENS USE BUT ONLY FOR OCCASIONAL USE. THIS INCIDENT IS BEING REPORTED TO THE UNCONFIRMED DIAGNOSIS OF OCULAR INFECTION OF UNKNOWN NATURE, SEVERITY, OR TREATMENT, AND THE POTENTIAL FOR SERIOUS OR PERMANENT INJURY, OR MEDICAL INTERVENTION OR MEDICATION TO PREVENT OR PRECLUDE SUCH OCCURRENCE, ASSOCIATED WITH SOME OCULAR INFECTIONS. SHOULD FURTHER INFORMATION BECOME AVAILABLE, THE MANUFACTURER WILL COMPLETE FURTHER INVESTIGATIONS AS APPROPRIATE AND SUBMIT A FOLLOW-UP REPORT AS APPLICABLE.
THIS INCIDENT WAS REPORTED TO THE MANUFACTURER BY THE CONTACT LENS PRESCRIBING OPTICIAN AS REPORTED TO THEM BY THE PATIENT. IT IS REPORTED THAT THE PATIENT IS A LONGTIME CONTACT LENS WEARER OF THIS SAME DEVICE. THE PATIENT WAS SEEN FOR A ROUTINE EYE APPOINTMENT AND REPORTED TO THE OPTICIAN AN INCIDENT WHICH OCCURRED APPROXIMATELY 10 WEEKS PRIOR. THE PATIENT WAS SEEN AT AN UNSPECIFIED HOSPITAL EYE SERVICES (HES) FOR AN UNSPECIFIED EYE INFECTION IN THE LEFT (OS) EYE. THE OPTICIAN IDENTIFIED 15 SCARS PRESENT DURING EXAM. DIAGNOSIS BY HES WAS NOT REPORTED, THE OPTICIAN SUSPECTS INFILTRATIVE KERATITIS BUT THIS HAS NOT BEEN CONFIRMED. PATIENT HAS RESUMED LENS USE BUT ONLY FOR OCCASIONAL USE. THIS INCIDENT IS BEING REPORTED TO THE UNCONFIRMED DIAGNOSIS OF OCULAR INFECTION OF UNKNOWN NATURE, SEVERITY, OR TREATMENT, AND THE POTENTIAL FOR SERIOUS OR PERMANENT INJURY, OR MEDICAL INTERVENTION OR MEDICATION TO PREVENT OR PRECLUDE SUCH OCCURRENCE, ASSOCIATED WITH SOME OCULAR INFECTIONS. SHOULD FURTHER INFORMATION BECOME AVAILABLE, THE MANUFACTURER WILL COMPLETE FURTHER INVESTIGATIONS AS APPROPRIATE AND SUBMIT A FOLLOW-UP REPORT AS APPLICABLE. NEW MEDICAL INFORMATION WAS RECEIVED (B)(6) 2025 FROM THE CONTACT LENS PRESCRIBING OPTICIAN, SPECSAVERS. THE OPTICIAN REPORTS THAT IN (B)(6) 2025 THE PATIENT WAS EXPERIENCING SORENESS IN THE LEFT (OS) EYE AND ATTENDED A&E AT (B)(6) HOSPITAL WHERE THE PATIENT WAS DIAGNOSED WITH A CORNEAL ABRASION. THE PATIENT WAS PRESCRIBED AN UNSPECIFIED EYE DROP AND ADVISED TO TEMPORARILY DISCONTINUE LENS USE FOR 8 WEEKS. WHEN THE PATIENT RETURNED FOR THEIR 8 WEEK FOLLOW-UP VISIT, THE PATIENT WAS ADVISED THEY HAD AN UNSPECIFIED OCULAR INFECTION AND GIVEN DIFFERENT (UNSPECIFIED) EYE DROPS. THE PATIENT WAS SEEN FOR FURTHER FOLLOW-UP AT THE HOSPITAL SERVICES IN (B)(6) 2025 WHERE THEY WERE TOLD THE EVENT HAD RESOLVED AND COULD RESUME LENS USE BUT SUGGESTED ON A LIMITED BASIS. THE PATIENT ATTENDED THE SPECSAVERS LOCATION FOR A ROUTINE CONTACT LENS CHECK ON (B)(6) 2025 WITH NO SYMPTOMS AND NO INJECTION OR STAINING PRESENT AT EXAM, BUT 12-15 CORNEAL ULCERS SCARS PRESENT. THE OPTICIAN CONFIRMS THAT THE EVENT HAS FULLY RESOLVED WITH NO PERMANENT IMPACT TO VISUAL ACUITY AND PATIENT HAS RESUMED LENS USE ON AN OCCASIONAL BASIS, HOWEVER, THE PATIENT IS LEFT WITH CORNEAL SCARING AND CORNEAL OPACITIES IN THE CENTRAL 6MM OF THE CORNEA. THIS EVENT REMAINS REPORTABLE DUE TO THE UNKNOWN NATURE OR SEVERITY OF THE REPORTED INFECTION, AND UNCONFIRMED NECESSITY OF MEDICAL INTERVENTION OR MEDICATION TO PREVENT OR PRECLUDE SERIOUS OR PERMANENT INJURY OR IMPAIRMENT. SHOULD FURTHER INFORMATION BECOME AVAILABLE, THE MANUFACTURER WILL COMPLETE FURTHER INVESTIGATIONS AS APPROPRIATE AND SUBMIT A FOLLOW-UP REPORT AS APPLICABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2105779 | MISIGHT 1 DAY (OMAFILCON A) | MISIGHT 1 DAY (OMAFILCON A) | QIT | COOPERVISION MANUFACTURING, LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Female | Other |