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 |