FDA Adverse Event
Injury
Summary report: N
CIB STANDARD, -2.75
MDR report key: 988448
·
Received January 18, 2008
Report
- Report Number
- MW5005071
- Event Type
- Injury
- Date Received
- January 18, 2008
- Date of Event
- November 29, 2007
- Report Date
- January 18, 2008
- Manufacturer
- CIBA VISION
- Product Code
- LPL
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT CAME IN FOR EXAMINATION IN 2007. HER LAST EYE EXAM WAS 2006. SHE WAS 8 MONTHS PREGNANT AND COULD NOT WEAR HER CONTACT LENSES BECAUSE THEY FELT DRY. A NEW GLASSES PRESCRIPTION WAS GIVEN AND WAS FILLED, THE CONTACT LENS PORTION WAS NOT FILLED IN AND WAS WRITTEN AS DEFER FOR A LATER TIME. SHE WAS TOLD TO RETURNED AFTER PREGNANCY TO CONTINUE FIT. PT RETURNED IN 2007 STATING THAT THE SHOP HAD FILLED HER CONTACT LENSES BASED UPON HER GLASSES PRESCRIPTION. HER EYELIDS STILL AFTER ONE MONTH OF NOT USING THE CONTACT LENSES REVEALED PAPILLAE FROM MECHANICAL IRRITATION. DATE OF USE: 2006-2007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIB STANDARD, -2.75 | NONE | LPL | CIBA VISION | |||
| 2 | CIBA STANDARD -3.00 | NONE | LPL | CIBA VISION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |