FDA.reportPublic FDA data

MAUDE MDR 9878460

MDR report key
9878460
Report number
3006695864-2020-00200
Event key
0
Event type
3
Date of event
2019-09-26
Date received
2020-03-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SOMYATA NAGPAL
Address
1700 EAST ST. ANDREW PLACE SANTA ANA CA 92705 US
Phone
714-714-7142
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INTRALASEPATIENT INTERFACEJOHNSON & JOHNSON SURGICAL VISION, INC.HNOPI-RET590106AN60161103 R
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2501. R

Event Narratives#

N

Patient 1

(B)(4) 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. DEVICE EVALUATION: 1 PI WAS RETURNED WITHIN ITS ORIGINAL PACKAGING CONFIRMING THE REPORTED LOT NUMBER OF 60161103. A VISUAL INSPECTION OF THE RETURNED DEVICE DID NOT REVEAL ANY DAMAGE TO THE COMPONENTS AND ALL PARTS WERE ASSEMBLED CORRECTLY. SUCTION AND DIMENSIONAL TESTING WAS PERFORMED WITH ALL RESULTS WITHIN SPECIFICATION. THE REPORTED SUCTION LOSS ISSUE COULD NOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: PER MANUFACTURING RECORDS REVIEW REPORT, NO RELATED NON-CONFORMITY OR DEVIATIONS WERE ISSUED DURING MANUFACTURING THE PI LOT# 60161103. ALL DEVICES MET MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

D

Patient 1

IT WAS REPORTED SUCTION LOSS AFTER THE LASER FIRED WITH LESS THAN 2 SECONDS LEFT DURING THE SIDE CUT ON UNKNOWN EYE. THE SURGEON VISUALIZED THE SIDE CUT AND IT WAS TEMPORALLY DISPLACED APPROXIMATELY 1MM. DUE TO THE DISPLACEMENT THE FLAP, IT WAS NOT LIFTED AND THE PROCEDURE WAS ABORTED. THE PATIENT CAME BACK AND HAD PHOTOREFRACTIVE KERATECTOMY (PRK) ON (B)(6) 2019, WHICH WAS COMPLETED SUCCESSFULLY.