Z-1280-03

Phaco Needles, catalog #DP8115, with 15 degree needle taper, labeld in part***Non-sterile, Manufactured for...

Name: Z-1280-03 Phaco Needles, catalog #DP8115, with 15 degree needle taper, labeld in part***Non-sterile, Manufactured for...
Creator: Bausch & Lomb Incorporated
Published: 2003-08-25
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2003-08-25 / Terminated / root cause: labeling and UDI

FDA source

Bausch & Lomb Incorporated began a recall of Phaco Needles, catalog #DP8115, with 15 degree needle taper, labeld in part***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***... on 2003-08-25. The reason FDA records is "The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1280-03
Status: Terminated
Initiated: 2003-08-25
Posted: 2003-10-15
Terminated: 2003-12-15
Recalling firm: Bausch & Lomb Incorporated
Product: Phaco Needles, catalog #DP8115, with 15 degree needle taper, labeld in part***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box.
Product code: HQC Unit, Phacofragmentation
Reason for recall: The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Firm notified customers by phone and letter 8/25/2003 and advised of needle mix-up. Customers were requested to quarantine affected product and return product with response form.
Quantity in commerce: 44 boxes
Distribution: Product was sold to 6 direct accounts in FL, IA, WI, MA and IL. Product was additionally sold to 4 international distributors.
Product codes and lots: Julian date coded ''2003163''

Product code HQC

K952259Class IIStorz Microseal Dp8030 & Dp8045 Phacoemulsification NeedlesStorz Instrument Co. / cleared 1995-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)