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 04/09/2018

Event Type  Injury  

Manufacturer Narrative

Age or date of birth, sex, weight and ethnicity: unknown/ not provided.(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) 2018 and resulted in suboptimal results.Right eye (od) wavescan measurement -3.40+1.22x092.Left eye (os) wavescan measurement -3.72+0.44x102.On (b)(6) 2019 patient had enhancement using idesign measurement on od -1.89 +1.30x093.On (b)(6) 2019 patient had enhancement using idesign measurement on os -1.98+0.92x081.This report is for the wavescan.A separate report will be filed for the visx.

Manufacturer Narrative

H4: correction: in initial report, the manufacturer date provided was inadvertently reported as 07/30/2005, however the correct date is 7/30/2003.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed that no other complaints have been received for this production order number.The review of the device history record (dhr) for wavescan system showed that there were no issues or non-conformities.The system and its components met all specifications prior to being released.Manufacturing has been ruled out as a potential cause for the reported issue.Based on the investigation results, no corrective action has been issued.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.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: 11362475
• MDR Text Key: 233194216
• Report Number: 3006695864-2021-07241
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• 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