MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-16 for AQUA SOFT DAILY CONTACT LENS PWR: -2.25 BC: 8.8 DIA: 14.1 manufactured by Visco Vision Inc..
[183674306]
The us distributor has further checked with the patient. The vision loss has been recovered and back to normal.
Patient Sequence No: 1, Text Type: N, H10
[183674307]
From report mw5092347: i have been using 1-800-contacts for years to order my contacts that are prescribed by my optometrist. I use 1-day acuvue moist pwr: -2. 25 bc: 8. 5 dia: 14. 2. I see an optometrist yearly and have had the same prescription for years. I received a sample box of 1-800-contacts brand aquasoft dailies to try in my last shipment of accuvue moist dailies. The aquasoft contacts i was given was the same prescription that i use: -2. 25 left eye and -2. 50 right eye. I tried the sample contact briefly. I got an email with an offer for a free 2 wk supply if i ordered more. I ordered two more wks just to try them out (i normally order 90 day supply at once). On tuesday, (b)(6) 2020 i put the contacts in my eyes before work at 6:30 in the morning. I had some discomfort all day with a "sandy feeling" while at work. I did not have my glasses or another pair of contacts on me so i left them in because i can't work or see without contacts/ glasses. At 4:00 pm i took the contacts out and discarded them. I put on my glasses. I then progressively started having more and more pain increasing to severe pain. The pain was so severe, i was unable to open my eye. Had severe watering, and edema of my eyelid. At this point inspected the packaging of the aquasoft contact i used and noticed it had different "bc and dia" measurements. 1 immediately called the company and notified them of my findings and my symptoms. I notified them i was going to emergency room due to severe pain. I went to the (b)(6) emergency room at 9:45 pm and was there until approx 2:00 on (b)(6) 2020. I was diagnosed with a large corneal abrasion(s) on the left eye and bilateral iritis. I was given optical antibiotic drops, vigamox. On (b)(6) 2020 at 11:15 am, i was seen by an ophthalmologist, dr (b)(6) as referred by the pa? -c at (b)(6). I had an eye exam and a retinal scan. He confirmed the large corneal abrasion, continued the antibiotic drops, and was instructed to f/u with an ophthalmologist in 1 wk. I contacted the company, once again, to give them an update on my status. I was told i would be given a call back by their "health dept. " i did not receive a call. On (8)(6) 2020 i woke up with large decrease vision in my left eye and dizziness from the vision charge. I called dr (b)(6), an ophthalmologist and was immediately seen in her office. I was given a fluorescein scan and thorough eye exam. It was confirmed i had severe corneal abrasions, severe inflammation, and decreased vision in my left eye. Dr (b)(6) increased the frequency of the drops, preservative free rewetting drops and added an antibiotic ointment to be used nightly. I was notified to f/u this week. I called 1-800-contacts again to provide them with an update and also that i have not spoken to anyone from the company regarding my adverse event/ serious injury. I phoned dr (b)(6) on sunday (b)(6) that my vision in my left eye was not improving. I was seen in dr (b)(6) office the next day on (b)(6) at 4:00 pm to assess the condition of my eye and vision. I am continuing the regimen of my drops, she added a steroid drop, and i am to continue the nightly antibiotic ointment. Dr (b)(6) informed me that my vision in my left eye may never improve and an injury of that nature can permanently change my prescription. In 4-6 wks she will assess what my new prescription will be following the injury. I was unable to drive from (b)(6). My fiance and i both missed work on (b)(6) due to my injury and i was able to work shortened hours remotely from home the remaining days. I still have not received a response from (b)(6) as promised. I am following up with dr (b)(6) on (b)(6) to f/u on condition of my eyes. My contact prescription is pwr: -2. 25 bc: 8. 5 dia: 14. 2. The aqua soft contact. Pwr: -2. 25 bc: 8. 8 dia: 14. 1. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004529384-2020-00001 |
| MDR Report Key | 9834563 |
| Report Source | OTHER |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2018-05-31 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. EVAN HUANG |
| Manufacturer Street | NO. 1, XINGYE ST. |
| Manufacturer City | GUISHAN DIST., TAOYUAN 33341 |
| Manufacturer Country | TW |
| Manufacturer Postal | 33341 |
| Manufacturer G1 | VISCO VISION INC. |
| Manufacturer Street | NO. 1, XINGYE ST., |
| Manufacturer City | GUISHAN DIST., TAOYUAN 33341 |
| Manufacturer Country | TW |
| Manufacturer Postal Code | 33341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUA SOFT DAILY CONTACT LENS |
| Generic Name | LENSES, SOFT CONTACT, DAILY WEAR |
| Product Code | LPL |
| Date Received | 2020-03-16 |
| Model Number | PWR: -2.25 BC: 8.8 DIA: 14.1 |
| Lot Number | 392000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VISCO VISION INC. |
| Manufacturer Address | NO. 1, XINGYE ST., GUISHAN DIST., TAOYUAN 33341 TW 33341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-16 |