MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-23 for FOCUS DAILIES VISITINT (AQUA RELEASE) CBV92000494 manufactured by Ciba Vision Asian Mfg And Logistics Pte Ltd..
[134062779]
This investigation was reopened as the actual complaint product was returned. Investigation including root cause analysis is in progress and an update to the manufacturing review has been requested. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 to update any significant changes. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[134062780]
As reported by the patient via telephone on (b)(6) 2018, she felt irritation on (b)(6) 2018 after several hours of use. The patient visited the doctor on (b)(6) 2018 and was diagnosed with several white spots found on cornea and corneal epithelium defect. The eye care provider (ecp) instructed to revisit after two to three days. Unspecified eye drops and eye-ointment were prescribed; treatment modality and duration were not provided. Symptoms were not resolved. Additional information was received on (b)(6) 2018. The patient sought medical attention on (b)(6) 2018 and was prescribed with gatifloxacin ophthalmic eye drops, cefmenoxime hydrochloride and ofloxacin ophthalmic; treatment modality and duration were not provided. The patient did a follow up visit and was prescribed gentamicin sulfate ophthalmic eye drop and an unspecified internal medicine; treatment modality and duration were not provided. The patient was referred to another health care facility during her follow up visit on (b)(6) 2018. On the same day, the patient did another visit and was prescribed with moxifloxacin and cefmenoxime hydrochloride to be applied every hour and tobramycin to be applied six times a day. The patient was also prescribed with an unspecified eye ointment and loxoprofen sodium; treatment modality and duration were not provided. The patient was instructed to suspend lens wear, to return for a follow up visit and to avoid using the contact lens on the left eye. It was confirmed that the event was caused by the lens. The patient's corneal surface was rubbed to perform bacterial exam and to infiltrate medicine effectively. Patient's symptoms was reported as improving. Additional information was received on (b)(6) 2018, the patient revisited the ecp and was scheduled for another follow-up visit on (b)(6) 2018. Additional information was received on (b)(6) 2018 from the consumer. She did a follow up visit with her ecp on (b)(6) 2018 and confirmed that she had infective keratitis. Previously prescribed eye drops were instructed to be continued. Additional information was scheduled to be requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003657720-2019-00001 |
| MDR Report Key | 8272306 |
| Date Received | 2019-01-23 |
| Date of Report | 2019-04-11 |
| Date of Event | 2018-12-01 |
| Date Mfgr Received | 2019-03-20 |
| Device Manufacturer Date | 2018-05-03 |
| Date Added to Maude | 2019-01-23 |
| 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 | MS. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152231 |
| Manufacturer G1 | CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD. |
| Manufacturer Street | 133 TUAS SOUTH AVENUE 3 |
| Manufacturer City | TUAS 637550 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 637550 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FOCUS DAILIES VISITINT (AQUA RELEASE) |
| Generic Name | LENS, CONTACT, (DISPOSABLE) |
| Product Code | MVN |
| Date Received | 2019-01-23 |
| Returned To Mfg | 2018-12-17 |
| Model Number | NA |
| Catalog Number | CBV92000494 |
| Lot Number | C0346358 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD. |
| Manufacturer Address | 133 TUAS SOUTH AVENUE 3 TUAS 637550 SN 637550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-23 |