| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00164-1 |
| Product Name/Description |
HOYA One-Piece Intraocular Lenses (IOL)
Models : HOYA AF-1 iMICS1 (NY-60), HOYA AF-1 Toric (311), HOYA iSert (250 and 251), HOYA iSert Toric (351)
Affected Serial numbers ranges:
KULX0011 - KUMZ0TN2)
JKLX0012 - JKN10CE4
JLLX0012 - JLN116T6
PNLX0012 - PNMZ04Q8
PPLX0011 - PPMZ01C8
PQLX0021 - PQMZ00E7
PRLX0011 - PRMZ00R6
PSLX0012 - PSMZ0078
PTLX0011 - PTMZ0048
PULX0011 - PUMZ00E8
PALY0011 - PAM200S6
PBLY0011 - PBM200C8
PCLY0011 - PCM200N8
ARTG: 117417 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
This recall/hazard alert is being undertaken following higher than expected reported rates of inflammation and/or endophthalmitis from doctors using NY-60, iSert 250, and iSert 251 IOLs in a few countries. An extensive review of the manufacturing process by Hoya revealed that some products had trace residual foreign particulates on them. |
| Recall Action |
Recall |
| Recall Action Instructions |
Please quarantine and return all the affected stock to Designs For vision Pty Ltd. For any patient already implanted with one of the lenses included in this recall. For any patient already implanted with one of the lenses included in this recall, Hoya is recommending follow-up with the patient at three (3) and six (6) months post-operatively to monitor for the possible onset of ocular inflammation. Patients should be reviewed earlier, or as needed, if symptomatic. For more details, please see http://www.tga.gov.au/safety/alerts-device-hoya-intraocular-lenses-130403.htm#consumers . |
| Contact Information |
1800 225 307 - Customer Service |