FDA Medical Device Recalls (openFDA)
Allergan Medical Optics Inc: AMO PhacoFlex II Model SI40NB, Intraocular Lenses
- Recall number
- Z-1036-03
- Recalling firm
- Allergan Medical Optics Inc
- Product
- AMO PhacoFlex II Model SI40NB, Intraocular Lenses
- Status
- Terminated
- Initiated
- 2003-07-02
- Posted
- 2003-07-22
- Terminated
- 2004-04-30
- Reason
- Post operative complaints of cloudiness in the intraocular lenses.
- Root cause
- Other
- Action
- Notification letters were sent July 2, 2003 to distributors and subdistributors. Customers were sent letters July 3 and 8, 2003.
- Quantity
- 98
- Distribution
- Brazil only.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P880081"]
- Product code
- not on file
- Firm FEI
- 3003843509
- Firm city
- Santa Ana
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28