Z-1006-2023Class II

FUSION Dual Pump Packs, REF: OPO73

Name: Z-1006-2023 FUSION Dual Pump Packs, REF: OPO73
Creator: Johnson & Johnson Surgical Vision, Inc.
Published: 2022-12-07
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2022-12-07 / Open, Classified / root cause: manufacturing process

FDA source

Johnson & Johnson Surgical Vision, Inc. began a recall of FUSION Dual Pump Packs, REF: OPO73 on 2022-12-07. FDA classified it as Class II and gives the reason as "Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1006-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-07
Posted: 2023-01-20
Recalling firm: Advanced Medical Optics, Inc.
Product: FUSION Dual Pump Packs, REF: OPO73
Product code: HQC Unit, Phacofragmentation
Reason for recall: Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 12/07/22, recall notices were sent to customers who were asked to do the following: 1) Discontinue using affected product. 2) Return product to the recalling firm. 3) Complete and return the Customer Reply form via email to [email protected] 4) Distributors, distribute the recall notice to your customers. Customers with questions or concerns can call the firm at 1-877-266-4543 Option 2.
Quantity in commerce: 7644
Distribution: US: FL, MS, NY, TN, TX, IL, MN, OH. OUS: Belgium, China, Estonia, France, Germany, Indonesia, Italy, Japan, Malaysia, Netherlands, Portugal, Sri Lanka, Switzerland, Thailand, United Kingdom
Product codes and lots: UDI-DI/Lots: 15050474602080/60373238, 60394037, 60308197

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1006-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1005-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-20
Z-1006-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-20
Z-1007-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-20

Product code HQC

K160236Class IIDual Pump PackAbbott Medical Optics, Inc. / cleared 2016-04-27

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)