FDA Adverse Event
Injury
Summary report: N
ACUVUE ADVANCE FOR ASTIGMATISM
MDR report key: 1022513
·
Received March 31, 2008
Report
- Report Number
- 1033553-2008-00047
- Event Type
- Injury
- Date Received
- March 31, 2008
- Report Date
- March 31, 2008
- Manufacturer
- VISTAKON
- Product Code
- LPL
- PMA / PMN Number
- K032340
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
A PT SENT AN EMAIL 3/6/2008, INDICATING THAT THE PT EXPERIENCED IRRITATION IN BOTH EYES AND AN " INFECTION" IN ONE EYE, WHILE WEARING ACUVUE ADVANCE FOR ASTIGMATISM LENSES. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE PT TO OBTAIN ADDITIONAL INFO; THE PT HAS NOT RESPONDED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, WILL REPORT ANY INFO RECEIVED WITHIN 30 DAYS OF RECEIPT. BASED ON THE LIMITED INFO RECEIVED THIS EVENT IS BEING REPORTED AS A SERIOUS INJURY AS A WORST CASE. ALL MDR'S ARE REVIEWED AT QUARTERLY MANAGEMENT REVIEW MEETINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUVUE ADVANCE FOR ASTIGMATISM | SOFT CONTACT LENS | LPL | VISTAKON | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |