MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC OPHTHALMIC REFRACTOMETER; REFRACTOMETER, OPHTHALMIC

Model Number 0070-0150

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

It was reported that patient was treated on (b)(6) 2020 and resulted in suboptimal results.Right eye (od) wavescan measurement -5.40+0.37x072.Left eye (os) wavescan measurement -6.28+0.85x092.On (b)(6) 2020 patient had enhancement using idesign measurement on od -1.02+0.07x180.On (b)(6) 2021 patient had enhancement using idesign measurement on os -1.81+0.48x093.This report is for the wavescan.A separate report will be filed for the visx.

Manufacturer Narrative

Section h3: device evaluated by manufacturer? yes.Section h4: correction: in initial report, the manufacturer date provided was inadvertently reported as 07/30/2005, however the correct date is 07/30/2003.A review of the records related to this equipment that included labeling, manual, and risk documentation reviews for this equipment was performed.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.All pertinent information available to johnson & johnson surgical vision has been submitted.

• Brand Name: OPHTHALMIC REFRACTOMETER
• Type of Device: REFRACTOMETER, OPHTHALMIC
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 11355830
• MDR Text Key: 232825723
• Report Number: 3006695864-2021-07224
• Device Sequence Number: 1
• Product Code: HKO
• UDI-Device Identifier: 0(01)(21)70620
• UDI-Public: (01)(21)70620
• Combination Product (y/n): N
• 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
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0070-0150
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VISX SERIAL # (B)(6)
• Patient Outcome(s): Required Intervention