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 FOCUS VISITINT manufactured by Unk.
[20430502]
Serious injury involving one person on 4/20/1998, pt mentioned to ciba consultant of inability to wear lenses due to ulcer in right eye, date of event: unk; lens model/water content: focus visitint/55%; eye involved: right; refraction: hyperopia; duration of use (months) wearing modality: 11; number of day lens worn: unk; lost visit to practitioner prior to symptoms: 5/1997; type of lens care system used: unk; name of disinfecting system used: unk; homemade saline used: no; number days worn between cleaning & disinfecting: unk; days between cleaning and symptoms: unk; days between symptoms and calling dr: not reported; 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: unk; results of corneal biopsy and/or scrapings: unk; clinical diagnosis: not reported; prognosis: based on consumer comments, she will resume lens wear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681121-1998-00009 |
| MDR Report Key | 167777 |
| Report Source | 05 |
| Date Received | 1998-05-18 |
| Date of Report | 1998-05-18 |
| Date of Event | 1998-01-01 |
| Date Mfgr Received | 1998-04-20 |
| 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 | FOCUS VISITINT |
| Generic Name | SOFT CONTACT LENS |
| Product Code | LRX |
| Date Received | 1998-05-18 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 7634014 |
| 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 | 163237 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| 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 |