MAUDE Adverse Event Report: COOPERVISION MANUFACTURING, LTD. MISIGHT 1 DAY (OMAFILCON A)

Lot Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Insufficient Information (4580)

Event Date 05/01/2021

Event Type  Injury  

Event Description

This incident was reported by the users treating facility, (b)(6) department.It is reported that a (b)(6) year old user (patient) developed double vision and a sudden onset of esotropia (squint) following a short period of use with the device for the first time.The contact lenses were prescribed, indicated for myopia management, by the users primary care optometrist who advised the user has no previous history of strabismus.Good faith efforts have been made to obtain further information without success.It is noted that the patient is scheduled to be seen at the eye unit on 30 november and will be supplying records from the prescribing optometrist.It is anticipated the further information is to be provided to the manufacturer after this date and follow-up report(s) to be submitted as appropriate.As of the date of this report, additional information is unknown.This event is being reported in an abundance of caution due to unconfirmed diagnosis, lack of medical information, and unknown patient outcome.

Manufacturer Narrative

No lenses received for evaluation and no lot number provided, further investigation cannot be completed at this time.It is unknown if the device caused or contributed to the patient's condition.Patient is expected to be seen 30 november by treating physician, manufacturer anticipates the return of additional medical information after that date.Investigation to be determined based on further information provided and follow-up report(s) to be submitted as appropriate.

Manufacturer Narrative

(h3): no lenses received for evaluation and no lot number provided, further investigation cannot be completed at this time.It is unknown if the device caused or contributed to the patient's condition.The relationship between the coopervision device and the event is unconfirmed.This event is being reported in an abundance of caution.Should further information become available, the manufacturer will complete further investigations as appropriate and submit a follow-up report as applicable.

Event Description

This incident was reported by the users treating facility, royal devon & exeter optometry department.It is reported that a 12 year old user (patient) developed double vision and a sudden onset of esotropia (squint) following a short period of use with the device for the first time.The contact lenses were prescribed, indicated for myopia management, by the users primary care optometrist who advised the user has no previous history of strabismus.Additional medical information received from treating physician, including historical medical records from patients primary/prescribing physician.Additional medical information received from treating physician, including historical medical records from patients primary/prescribing physician.In summary, patient has on onset of double vision earlier this year which she thinks started when she began wearing misight lenses, there was also an increase in her myopic correction at this point.There is evidence that she had a history of a latent convergent squint before the increase in myopia and wearing the misight lenses but no record of diplopia.The patient does have very reduced negative fusional vergence, there is no sign of incomitance of deviation although her squint has increased slightly since we first saw her in (b)(6) 2021.She has had a normal mri scan in (b)(6) 2021.There is a question of whether the peripheral blur using misight lenses contributed to decompensation of an esophoria.Patient is no longer using contact lenses and is wearing spectacles to correct myopia with a fresnel prism to control diplopia.Patient is listed for squint surgery to correct her esotropia but does not have a date scheduled as of the date of this report.Patient is diagnosed with late onset esotropia.A symptom of diplopia could be a possible complaint while wearing misight lenses.In some wearers, especially if larger pupils, the treatment zones may create ghosting.This could be reported as double vision or diplopia.Since this is due to the lens optics, it would not persist after lens removal.Additionally, the patient had exhibited esophoria at near at most other visits (with one possible report of exophoria that would be questionable).Potentially, if the lens was over-minused, the extra accommodation could increase the degree of esophoria while wearing the lenses and potentially could appear to be an esotropia.However, this also would not persist after removal of the lenses.

• Brand Name: MISIGHT 1 DAY (OMAFILCON A)
• Type of Device: MISIGHT 1 DAY (OMAFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD.; chandlers ford, erith house; warrior close; eastleigh, hampshire SO53 4TE; UK SO53 4TE
• Manufacturer (Section G): COOPERVISION MANUFACTURING, LTD.; chandlers ford, erith house; warrior close; eastleigh, hampshire SO53 4TE; UK SO53 4TE
• Manufacturer Contact: melissa torpey ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 5857569874
• MDR Report Key: 12862759
• MDR Text Key: 281195258
• Report Number: 3003981983-2021-00003
• Device Sequence Number: 1
• Product Code: QIT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P180035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 YR
• Patient Sex: Female