MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2019-05-30 for FOCUS DAILIES VISITINT (AQUA RELEASE) CBV92000393 manufactured by Ciba Vision Asian Mfg And Logistics Pte Ltd..
[146509188]
No sample was returned for verification. There was no other complaint received for this complaint lot since it was released on (b)(6) 2018. All the in-process sampling inspections did not identify any defect for this complaint lot and all results were within specifications. Furthermore, the in-process controls were all in place and no deviations were observed to the controls during the manufacturing of this lot. Retained sample evaluation was performed and results for all tested parameters were found to be within specification. All investigation results showed that no deviations were observed during the manufacturing of this complaint lot. The aql of this lot met the acceptance criteria and the final release testing results for this lot met specifications. All equipment (linear table, primary packaging, autoclave) associated with the manufacture of this lot was found to be acceptable. Saline and environment were reviewed. All tests conducted passed, and no abnormalities were found. No root cause could be identified. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146509189]
It was reported by a female consumer on (b)(6) 2019 via website that her right eye (od) contact lens gave her pain "two weeks ago". Another pain episode occurred on (b)(6) 2019 and she found out that the contact lens was broken in more than two parts. She went to a hospital and they removed it but they diagnosed her with "cornea damage". She was prescribed with an eye gel containing sodium hyaluronate and xanthan gum for 14 days. Symptoms were continuing. Additional information received on (b)(6) 2019 stated that the lens broke into three parts and the consumer did not keep it. The ophthalmologist found corneal lesions and he prescribed the eye gel to be used "1 application 3 times per day for 10 days on right eye. I would suggest to avoid the use of contact lenses". The consumer will have a check up after the treatment period. She was using glasses because her right eye was still "annoying" her. Additional information has been requested but not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003657720-2019-00003 |
| MDR Report Key | 8654183 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-30 |
| Date of Event | 2019-05-03 |
| Date Mfgr Received | 2019-05-04 |
| Device Manufacturer Date | 2018-04-23 |
| Date Added to Maude | 2019-05-30 |
| 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 | 3 |
| Brand Name | FOCUS DAILIES VISITINT (AQUA RELEASE) |
| Generic Name | LENS, CONTACT, (DISPOSABLE) |
| Product Code | MVN |
| Date Received | 2019-05-30 |
| Model Number | NA |
| Catalog Number | CBV92000393 |
| Lot Number | C0345932 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-30 |