MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-05-18 for NEW VUES manufactured by P.t. Ciba Vision Batam.
[15378915]
Serious injury involving one person. On 4/20, pt reported to his dr complaining of tearing, pain, and photophobia in right eye, lens model/water content: newvues/55%; lot #8423015; eye involved: right: refraction: myopia; duration of use (months) wearing modality; trial lens period/no report of dispense date; number of days lens worn: unk; last visit to practitioner prior to symptoms: unk; type of lens care sytem used: unk; disinfecting system used: unk; was homemade saline used:no; number of days worn between cleaning and disinfecting: unk; days between cleaning and symptoms: unk; days between symptoms and calling dr: same day; self-treatment by pt: unk; hand washing before lens manipulation: unk; ulcer location: unk; visual acuity before symptoms: unk; visual acuity after symptoms: unk; results of culture: not reported; results of corneal biopsy and/or scrapings: unk; clinical diagnosis: pt reports corneal ulcer; treatment administered: unk; prognosis: pt states condition improving with follow-up scheduled 5/07/98.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681121-1998-00010 |
| MDR Report Key | 167747 |
| Report Source | 05 |
| Date Received | 1998-05-18 |
| Date of Report | 1998-05-18 |
| Date of Event | 1998-04-20 |
| Date Mfgr Received | 1998-04-23 |
| Date Added to Maude | 1998-05-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEW VUES |
| Generic Name | DISPOSABLE SOFT CONTACT LENS |
| Product Code | LRX |
| Date Received | 1998-05-18 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 8423015 |
| ID Number | P820021 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 163213 |
| Manufacturer | P.T. CIBA VISION BATAM |
| Manufacturer Address | BATAM INDUSTRIAL PARK, LOT 204 MUKA KUNING BATAM ISLAND ID |
| Baseline Brand Name | FOCUS VISITINT |
| Baseline Generic Name | SOFT CONTACT LENS |
| Baseline Model No | NA |
| Baseline Catalog No | NA |
| Baseline ID | P820021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-05-18 |