MAUDE Adverse Event Report: PARAGON VISION SCIENCES, INC. PARAGON CRT 100; LENS, CONTACT, ORTHOKERATOLOGY, OVERNIGHT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Acanthameba Keratitis (1945); Eye Infections (4466)

Event Date 10/30/2023

Event Type  Injury  

Event Description

This event occurred in china.The patient developed discomfort at the end of october and came to our hospital for treatment on (b)(6).He was given antiviral treatment.However, he did not improve.He came to the hospital on november 16 to check for amoebae under a confocal microscope.He was prescribed levofloxacin hydrochloride and voriconazole for injection.Apply to the right eye, once an hour, and administer tobramycin eye drops to the right eye, six times a day.Some relief occurred on (b)(6).Bacterial and fungal cultures were performed on the lens and lens case.A large number of bacteria and fungi were found.Parents were consulted.It was later learned that the patient's lens had been soaked in hydrogen peroxide for more than 10 days without any treatment, and the patient's care is now being considered.Detailed follow- up timeline: (b)(6), 2023: the patient was reviewed in the third week.The patient claimed that he did not wear the lens continuously.The visual acuity of the right eye was 0.5, the left eye was 0.8, the cornea was transparent, and no hyperemia in conjunctiva of both eyes.He was advised to wear lens continuously and review again one month later.(b)(6) 2023: due to redness and photophobia in the right eye, the patient came to the hospital for examination.The eyelid of the right eye was slightly spasmed, mixed congestion, the conjunctival sac was still clean, and the superficial gray-white infiltration of the cornea at 3 o'clock and 8 o'clock was visible, with mild edema.Dendritic lesions, unclear edges, 2% fl, kp, decreased corneal sensation, no pyon in the anterior chamber, round pupils, and slow reaction to light.Doctor's advice: 1) 0.1% sodium hyaluronate eye drops (sea dew) 1.0 drops in the right eye four times a day, 1.0 drops 0.15% ganciclovir ophthalmic gel in the right eye once before going to bed, 0.1% more often aciclovir eye drops 1.0 drops in the right eye once an hour; 2.) avoid cross-infection; 3) pay attention to exercise, improve resistance, and prevent colds.If the virus infection may relapse; 4) eat a light diet and eat foods rich in protein and vitamins; 5) pay attention to eye cleanliness, follow the doctor's instructions when taking medication, and follow up once a week or when feel not good.(b)(6) 2023: he was treated with ganciclovir eye solution, but the symptoms were not relieved and he went to (b)(6) hospital for treatment.Right eye: corneal stromal infiltration and turbidity can be seen in the temporal inferior part of the cornea and the nasal corneal surface.The remaining cornea is clear, kp, 2% fl, doctor's advice: 1)pay attention to eye hygiene and stop wearing lens.2) ganciclovir eye drops (self-prepared) for the right eye once an hour, ganciclovir gel (self-prepared) for the right eye once before bed, sodium hyaluronate eye drops (self-prepared) for the right eye 4 times a day second-rate.3) recheck in 3-5 days and follow up if any discomfort occurs.(b)(6), 2023: main claim: the right eye is still red and painful, photophobic, and blurred vision.Right eye: mild eyelid swelling, obvious spasm, conjunctival hyperemia, diffuse corneal edema, lesions located on the nasal side of the pupil area and dendritic shape in the inferior temporal quadrant, superficial stromal infiltration of 2% fl is only scattered on the surface of the lesion, with punctate staining of kp dingdow's sign pupil.Doctor's advices: 1) valacyclovir hydrochloride dispersible tablets 0.3 g orally twice a day, 20% calf blood deproteinized extract eye drops 1.0 drops in the right eye four times a day, 0.3% tobramycin eye drops solution (topex) 1.0 drops in the right eye three times a day; 2) prepare your own medicine ganciclovir eye drops sea dew gel to reduce eye use, get enough sleep, have a balanced diet, strengthen nutrition, avoid colds and eye trauma, and increase immunity.3) eye hot compress massage 4) recheck after 1 week.(b)(6), 2023: main claim: same medical history as before; blepharospasmodic closure of the right eye; mixed congestion in the right eye; localized radial infiltration of corneal lesions, stromal edema, 2% fl.Doctor's advice: 1) pay attention to eye hygiene.2) levofloxacin hydrochloride eye drops 1.0 drops for the right eye once an hour, 2.0 ml of sterile water for injection for the right eye once an hour, voriconazole 0.1 g for injection for the right eye once an hour , tobramycin eye drops 1.0 drops in the right eye six times a day; 3) explain the condition: professor sun will have a follow-up examination at the outpatient clinic this week.Follow up if any discomfort occurs.(b)(6), 2023: main claim: medical history is the same as before.Right eye: mixed conjunctival congestion, turbidity and edema in the center of the cornea and nasal side, and radial infiltration foci were visible from 1 o'clock to the center of the pupil.Doctor's advice: 1) pay attention to eye hygiene.2) continue taking the same medication as before.3) reexamination in 1 week and follow-up for any discomfort.(b)(6), 2023: the patient's re-examination showed that the right eye was mixed and congested; the lesion was localized, and a 1*1m white opaque body was visible at the upper edge of the pupil at 12 o'clock, 2% fl.Doctor's advice: 1) pay attention to eye hygiene.2) explain the condition, review the patient in 2 weeks, and follow up if any discomfort occurs.(b)(6), 2023: the patient's reexamination showed mixed congestion in the right eye; localized lesions; thinning of the 12-point lesion; a small amount of opacity in the pupil area, 2% fl.Doctor's advice: 1) pay attention to eye hygiene.2).Voriconazole eye drops for the right eye once an hour; hailu eye drops for both eyes once an hour.3) explain the condition: re-examination in 1 week, follow-up for discomfort.(b)(6), 2023: the patient came to the (b)(6) hospital for a follow-up check.There was no hyphae in the right eye, the visual acuity was 0.2, and the corrected visual acuity was 0.8.The prognosis is good and the family members are satisfied.They are currently following the doctor's instructions to continue taking the medication and then stop taking it for review.The clinical optometry department of the hospital is in close contact.

Manufacturer Narrative

The lens was not returned to paragon for inspection.Review of the device history record found that the quality control (qc) batch for each lens met release requirements.The investigation determined that the lenses met manufacturing release requirements and the discomfort may have been caused by insufficient cleaning or storage of the lens.Paragon medical review team determined that viral eye infection occurred during lens wear and was not due to the lens wear.Patient's prognosis is good and currently following the doctor's instructions to continue taking the medication and then stop taking it for review.

Event Description

This event occurred in china.The patient developed discomfort at the end of october and came to our hospital for treatment on november 5.He was given antiviral treatment.However, he did not improve.He came to the hospital on (b)(6) to check for amoebae under a confocal microscope.He was prescribed levofloxacin hydrochloride and voriconazole for injection.Apply to the right eye, once an hour, and administer tobramycin eye drops to the right eye, six times a day.Some relief occurred on (b)(6).Bacterial and fungal cultures were performed on the lens and lens case.A large number of bacteria and fungi were found.Parents were consulted.It was later learned that the patient's lens had been soaked in hydrogen peroxide for more than 10 days without any treatment, and the patient's care is now being considered.Detailed follow- up timeline: (b)(6) 2023: the patient was reviewed in the third week.The patient claimed that he did not wear the lens continuously.The visual acuity of the right eye was 0.5, the left eye was 0.8, the cornea was transparent, and no hyperemia in conjunctiva of both eyes.He was advised to wear lens continuously and review again one month later.(b)(6) 2023: due to redness and photophobia in the right eye, the patient came to the hospital for examination.The eyelid of the right eye was slightly spasmed, mixed congestion (+), the conjunctival sac was still clean, and the superficial gray-white infiltration of the cornea at 3 o'clock and 8 o'clock was visible, with mild edema.Dendritic lesions, unclear edges, 2% fl(+), kp(-), decreased corneal sensation, no pyon in the anterior chamber, round pupils, and slow reaction to light.Doctor's advice: 1) 0.1% sodium hyaluronate eye drops (sea dew) 1.0 drops in the right eye four times a day, 1.0 drops 0.15% ganciclovir ophthalmic gel in the right eye once before going to bed, 0.1% more often aciclovir eye drops 1.0 drops in the right eye once an hour; 2.)avoid cross-infection; 3) pay attention to exercise, improve resistance, and prevent colds.If the virus infection may relapse; 4) eat a light diet and eat foods rich in protein and vitamins; 5) pay attention to eye cleanliness, follow the doctor's instructions when taking medication, and follow up once a week or when feel not good.(b)(6) 2023: he was treated with ganciclovir eye solution, but the symptoms were not relieved and he went to changsha aier eye hospital for treatment.Right eye: corneal stromal infiltration and turbidity can be seen in the temporal inferior part of the cornea and the nasal corneal surface.The remaining cornea is clear, kp(-), 2% fl(+).Doctor's advice: 1)pay attention to eye hygiene and stop wearing lens.2) ganciclovir eye drops (self-prepared) for the right eye once an hour, ganciclovir gel (self-prepared) for the right eye once before bed, sodium hyaluronate eye drops (self-prepared) for the right eye 4 times a day second-rate.3)recheck in 3-5 days and follow up if any discomfort occurs.(b)(6) 2023: main claim: the right eye is still red and painful, photophobic, and blurred vision.Right eye: mild eyelid swelling, obvious spasm, conjunctival hyperemia (++), diffuse corneal edema, lesions located on the nasal side of the pupil area and dendritic shape in the inferior temporal quadrant, superficial stromal infiltration of 2% fl is only scattered on the surface of the lesion, with punctate staining of kp (-) dingdow's sign (-) pupil (-).Doctor's advices: 1) valacyclovir hydrochloride dispersible tablets 0.3 g orally twice a day, 20% calf blood deproteinized extract eye drops 1.0 drops in the right eye four times a day, 0.3% tobramycin eye drops solution (topex) 1.0 drops in the right eye three times a day; 2) prepare your own medicine ganciclovir eye drops + sea dew gel to reduce eye use, get enough sleep, have a balanced diet, strengthen nutrition, avoid colds and eye trauma, and increase immunity.3) eye hot compress massage 4)recheck after 1 week.(b)(6) 2023: main claim: same medical history as before; blepharospasmodic closure of the right eye; mixed congestion (++) in the right eye; localized radial infiltration of corneal lesions, stromal edema, 2% fl (+).Doctor's advice: 1) pay attention to eye hygiene.2) levofloxacin hydrochloride eye drops 1.0 drops for the right eye once an hour, 2.0 ml of sterile water for injection for the right eye once an hour, voriconazole 0.1 g for injection for the right eye once an hour , tobramycin eye drops 1.0 drops in the right eye six times a day; 3) explain the condition: professor sun will have a follow-up examination at the outpatient clinic this week.Follow up if any discomfort occurs.(b)(6) 2023: main claim: medical history is the same as before.Right eye: mixed conjunctival congestion++, turbidity and edema in the center of the cornea and nasal side, and radial infiltration foci were visible from 1 o'clock to the center of the pupil.Doctor's advice: 1) pay attention to eye hygiene.2) continue taking the same medication as before.3) reexamination in 1 week and follow-up for any discomfort.(b)(6) 2023: the patient's reexamination showed that the right eye was mixed and congested (+); the lesion was localized, and a 1*1m white opaque body was visible at the upper edge of the pupil at 12 o'clock, 2% fl (-).Doctor's advice: 1)pay attention to eye hygiene.2) explain the condition, review the patient in 2 weeks, and follow up if any discomfort occurs.(b)(6) 2023: the patient's reexamination showed mixed congestion (+) in the right eye; localized lesions; thinning of the 12-point lesion; a small amount of opacity in the pupil area, 2% fl (-).Doctor's advice: 1) pay attention to eye hygiene.2).Voriconazole eye drops for the right eye once an hour; hailu eye drops for both eyes once an hour.3) explain the condition: re-examination in 1 week, follow-up for discomfort.(b)(6) 2023\: the patient came to the international department of changsha aier hospital for a follow-up check.There was no hyphae in the right eye, the visual acuity was 0.2, and the corrected visual acuity was 0.8.The prognosis is good and the family members are satisfied.They are currently following the doctor's instructions to continue taking the medication and then stop taking it for review.The clinical optometry department of the hospital is in close contact.

Manufacturer Narrative

The lens was not returned to paragon for inspection.Review of the device history record found that the quality control (qc) batch for each lens met release requirements.The investigation determined that the lenses met manufacturing release requirements and the discomfort may have been caused by insufficient cleaning or storage of the lens.Paragon medical review team determined that viral eye infection occurred during lens wear and was not due to the lens wear.Patient's prognosis is good and currently following the doctor's instructions to continue taking the medication and then stop taking it for review.

• Brand Name: PARAGON CRT 100
• Type of Device: LENS, CONTACT, ORTHOKERATOLOGY, OVERNIGHT
• Manufacturer (Section D): PARAGON VISION SCIENCES, INC.; 2120 west guadalupe road,; gilbert AZ 85233 2810
• Manufacturer (Section G): PARAGON VISION SCIENCES, INC.; 2120 west guadalupe road; gilbert AZ 85233 2810
• Manufacturer Contact: mrunmayee patil ; 2120 west guadalupe road; gilbert, AZ 85233-2810 ; 4805077608
• MDR Report Key: 18341027
• MDR Text Key: 330664889
• Report Number: 3013398957-2023-12032
• Device Sequence Number: 1
• Product Code: NUU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P870024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/16/2023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 YR
• Patient Sex: Male