| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01377-1 |
| Product Name/Description |
Various Acuvue for Astigmatism Contact Lenses
Acuvue Oasys for Astigmatism, 8.6 -6.00 -1.75/170 6P and 8.6 -3.50 -0.75/180 6P
Lot Numbers: B00GW4Z and B00HRMG
Expiry: Nov 2018 and Jul 2019
Acuvue Oasys, 8.8 -04.00 6P RX
Lot: L002NCS
Expiry: May 2020
Acuvue Oasys, 8.8 -04.50 6P
Lot: L002QH9
Expiry: Aug 2020
1 Day Acuvue Moist for Astigmatism, 8.5 -7.50 -1.25/180 90P
Lot: F00LF41
Expiry: Apr 2021
ARTG Numbers: 223534, 223535, 223536 and 154490 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
1/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Johnson & Johnson Vision Care (JJVC) has identified quality issues identified with specific batches of Acuvue Contact Lenses.
A limited number of confirmed reports were received in relation to a foreign matter visible within the contact lens package and a lens being “off power”.
Foreign Matter - A limited number of reports of a brush bristle found between the blister package and foil have been received.
Off Power - A limited number of confirmed reports of a lens being “off power” have been received, where a consumer may recognise as not accurately correcting the vision in one eye (some distortion or blurriness). Not all lenses in these lots are affected and there is no significant health risk related to this issue.
To date, there have been no adverse events related to these issues. |
| Recall Action |
Recall |
| Recall Action Instructions |
Eye Care Professionals are advised to check stock and quarantine the affected lot numbers. Affected stock can be returned for unaffected product.
This action has been closed out on 16/08/2018. |
| Contact Information |
1800 736 912 - ACUVUE Support |