MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. LAMINAR; UNIT, PHACOFRAGMENTATION

Model Number OPOHF21L

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2022

Event Type  Injury  

Manufacturer Narrative

Patient weight: unknown/not provided, ethnicity and race: unknown/not provided, date of event: unknown/not provided.Lot#: per customer the lot number is unknown, however based on their stock it could be lot 60334477 or 60309888.Expiration date: unknown as product lot number was not provided.Udi #:is unknown as product lot number was not provided.Device manufacture date: unknown, as the lot number of the device was not provided.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing record could not be reviewed since the lot number was not provided.Conclusion: as a result of the investigation and based on limited information available, it cannot be determined if there is a product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during the end of the irrigation and aspiration with a signature pro phaco unit, the end of the irrigation and aspiration sleeve broke off and lodged just inside the primary wound.Surgeon removed it with forceps and completed the procedure without further incidence.There were no complications or additional intervention required.Patient outcome was reportedly satisfactory.Further it was reported that staff is not sure about the lot used, however the supplies right now at the surgery center are lot numbers 60334477 and 60309888.No further information provided.

Manufacturer Narrative

Correction the following information was known at the time of this report however, it was inadvertently not included in the initial report: b1 - adverse event checkbox should not have been mark.B2 - required intervention to prevent permanent impairment/damage (devices) checkbox.Should not have been mark.H6 - medical device problem code - 1069 code no longer applies.The correct code is 2976.H6 - health effect - impact code 4625 code no longer applies.The correct code is 2199.

• Brand Name: LAMINAR
• 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: 13980949
• MDR Text Key: 293162501
• Report Number: 3012236936-2022-00696
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: OPOHF21L
• Device Catalogue Number: OPOHF21L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female