MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. UNK_I/A HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number UNK_I/A HANDPIECE

Device Problem Contamination (1120)

Patient Problems Inflammation (1932); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

Section a3, a4 and a5: information requested however, not provided.Section d4: serial #: unknown/not provided.Section d4: expiration date: unknown, as the serial number of the device was not provided.Section d4: udi #: a complete udi # is unknown as product lot number was not provided.A partial number has been provided section e1 telephone number: +(b)(6).Section h4.Device manufacture date: unknown, as the serial number of the device was not provided.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : see h10.

Event Description

It was reported that there was minimal fragment noticed on left eye at one month post surgery.It was imbricated in temporal iris.After trying to remove it with a bimanual, the fragment sank further in the iris.There was an inflammatory reaction in the anterior chamber associated with it.It was initially reported that the patient was permanently impaired and it was affecting daily activities significantly.However, through follow up to clarify the permanent impairment, the doctor reported that there was no downside, no inflammation and good (visual) acuity.The doctor's concern is that is unknown if this fragment is ferromagnetic.No additional information was provided.

• Brand Name: UNK_I/A HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18843075
• MDR Text Key: 336960850
• Report Number: 3012236936-2024-00594
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K981116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_I/A HANDPIECE
• Device Catalogue Number: UNK - I/A HANDPIECE
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR