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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 02, 2003
Date Posted July 22, 2003
Recall Status1 Terminated 3 on April 30, 2004
Recall Number Z-1036-03
Recall Event ID 26712
PMA Number P880081 
Product AMO PhacoFlex II Model SI40NB, Intraocular Lenses
Code Information 1011620109 1303290109 1011680109 1309920109 1038960109 1330610110 1039310109 1391120107 1077970111 1391590107 1077990111 1391930107 1104820203 1414530107 1123300203 1430530112 1149800001 1441910105 1162800105 1454360107 1167400105 1454380107 1168730109 1459930105 1189090109 1484520108 1191330109 1484570112 1191500109 1484650108 1192830105 1486950107 1192940105 1501090108 1207160105 1690550106 1213960109 1690810106 1214020109 1780720106 1215950109 1780740106 1216120109 1781220106 1224570111 1781340106 1227610105 1785280202 1232610109 1846620106 1232680109 1896320106 1232760109 1896330106 1237660109 1896420106 1237880109 1974109910 1276430109 9909772334  1010640212 1012010212 1012040212 1286460208 1299700208 1299760208 1299770208 1324100211 1324110211 1324530211 1384980211 1392500211 1408400211 1419200208 1445720211 1663700211 1670870211 1670890211 1672080211 1703760211 1721900211 1797030210 1956470211 1963580210 1990660211 1991080211 1993620211 1993660211 2121580206 2121690206   Known Implanted Lenses  1704120211 1990690211  
Recalling Firm/
Manufacturer		 Allergan Medical Optics Inc
1700 E. St.Andrew Place
Santa Ana CA 92799
For Additional Information Contact Sandra F. Sevaggi
714-247-8656
Manufacturer Reason
for Recall		 Post operative complaints of cloudiness in the intraocular lenses.
FDA Determined
Cause 2		 Other
Action Notification letters were sent July 2, 2003 to distributors and subdistributors. Customers were sent letters July 3 and 8, 2003.
Quantity in Commerce 98
Distribution Brazil only.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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