MAUDE Adverse Event Report: UNK_PATIENT INTERFACE; KERATOME, AC-POWERED

Model Number UNK-PATIENT INTERFACE

Device Problem Decrease in Suction (1146)

Patient Problems Visual Impairment (2138); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  Injury  

Manufacturer Narrative

Weight, ethnicity: unknown/ not provided.Lot number, model number, device expiration date and udi number are unknown as product id was not provided.Device manufacture is unknown/ not provided.The patient interface (pi) suction ring may lose suction during a procedure.Label copy states corneal fixation vacuum loss can occur.There are several factors that may contribute to suction issues such as doctor¿s technique in applying the suction ring to the cornea, doctor¿s technique in squeezing the pi clip to secure the suction ring to the pi cone and patient anatomy affecting the interface between the patient¿s cornea and the suction ring.If there is any further relevant information, a supplemental medwatch will be filed.Device available for evaluation: no, device returned to manufacturer: no.Device evaluation: at the time of the investigation, product was not available for evaluation as it was discarded.Therefore, no testing could be performed.The reported event cannot be confirmed.Manufacturing record evaluation: for this reported event, lot # was not reported and cannot be obtained.Therefore, manufacturing record review cannot be performed.For this reported event, lot # was not reported and cannot be obtained.Therefore, complaint history review cannot be performed.Conclusion: based on the information obtained, product malfunction and product deficiency cannot be confirmed.No further investigation is required.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported by the customer that they experienced suction loss with the pi during the laser firing in left eye.Procedure was completed successfully with a new pi.There was no patient injury or surgical intervention needed.

Manufacturer Narrative

Additional information: b1: report type: adverse event serious injury.B2: outcomes attributed to adverse event: other serious (important medical events).B5: loss of 2 lines of best corrected visual acuity (bcva).Pre op bcva 20/20 -2.Post op bcva 20/30-1 at day 1.H1: type of reportable event: serious injury.H6: health effect - clinical code 2138 for loss of bcva.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : device was discarded.

• Brand Name: UNK_PATIENT INTERFACE
• Type of Device: KERATOME, AC-POWERED
• MDR Report Key: 12155841
• MDR Text Key: 261287199
• Report Number: 3006695864-2021-08034
• Device Sequence Number: 1
• Product Code: HNO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

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: UNK-PATIENT INTERFACE
• Device Catalogue Number: UNK-PATIENT INTERFACE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/12/2021
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 07/28/2021
• 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: Initial
• Patient Sequence Number: 1
• Treatment: LASER SN (B)(6).
• Patient Outcome(s): Other
• Patient Age: 20 YR