Recall Z-1976-2011 ยท LPL Lenses, Soft Contact, Daily Wear
CIBA Vision Puerto Rico, Inc.
SoftPerm (synergicon A) Daily Wear Contact Lenses, Rx Only, Sterile. Contents: One sterile contact lens, rigid center/soft hydrophilic skirt (25% water), in normal saline solution buffered with sodium bicarbonate. Ciba Vision Group, Duluth GA 30097 USA SoftPerm contact lenses are indicted for daily wear (class II device) for correction of visual accuracy for keratoconus and in non-aphakic persons
| Date | Apr 13, 2011 (initiated Feb 1, 2011) |
| Status | Terminated |
| Reason | Out of specification values were obtained for sterility testing. The pH of the saline solution may be higher than the spec (up to pH 8.6 compared to a spec limit of pH 7.8). The osmolarity of the saline solution may be lower than specification (263 mOsm/kg compared to a spec limit of 270) |
| Root cause | Other |
| Action | The firm, CIBA Vision, sent two letters of notification to its customers. First letter "IMPORTANT PRODUCT INFORMATION" dated June 2010 and the second "URGENT: Voluntary Product Recall" dated February 1, 2011. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: 1) complete the requested information on the attached SoftPerm (synergicon A) Lenses Reply Form and drop the form in the mail within 10 business days and 2) If they have any of the recalled SoftPerm (synergicon A) lenses (shipped to you after March 1, 2009) still in th |
| Quantity | 28, 124 |
| Distribution | Worldwide distribution: USA (nationwide) including PR; and countries including: Australia, Austria, Argentina, Bahrain, Belgium, Canada, Colombia, Czech Republic, Denmark, Dubai (United Arab Emirates), Finland, France, Great Britain, Greece, Hungary, Iceland, Israel, Italy, Jordan, Kuwait, Lebanon, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.