MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. WAVESCAN WS1; REFRACTIVE MEASUREMENT

Model Number 0070-0150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown/not provided.Manufacturing date: requested but not available at the time of this report.(b)(4).All specifications were met when system was checked.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.

Event Description

Account reported that patient presented with undercorrections.She explained that the humidity has dropped and has been around 30% lately as it usually happens in winter.All of the patients are customvue.No reported loss of best corrected visual acuity (bcva).Lasik surgery in (b)(6) 2019: right -4.25 +1.25 x 100, left -4.25 +1.50 x 115.Enhancement was done in (b)(6) 2019: right -2.00 +0.50 x 105, left -1.50 +1.25 x 125.This report is for the wavescan system.A separate report is being submitted for the visx laser.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

Manufacturer Narrative

Correction: h4 - manufacturing date - the manufacturing site reported that the manufacturing date for the device is 07/30/2003.

• Brand Name: WAVESCAN WS1
• Type of Device: REFRACTIVE MEASUREMENT
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9656403
• MDR Text Key: 178149715
• Report Number: 3006695864-2020-00081
• Device Sequence Number: 1
• Product Code: HKO
• UDI-Device Identifier: 0(01)(21)70620
• UDI-Public: (01)(21)70620
• Combination Product (y/n): Y
• PMA/PMN Number: K000327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0070-0150
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXCIMER SN (B)(6).
• Patient Outcome(s): Required Intervention