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

Model Number 0110-2261

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

Patient Problems Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)

Event Type  Injury  

Manufacturer Narrative

Sex, weight, ethnicity: unknown/ not provided.Date of event: unknown/not provided.Serial #: unknown/not provided.Udi #: unknown/not provided.Device manufacture date: unknown, as the serial number of the device was not provided.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 presented 3 months post lasik with complaints of glare and halo at night.Doctor reported that patient moved a lot during the surgery.The patients post op refraction is as follows: od +0.25-0.50@5 20/20, os +0.50-0.50@15 20/20.The patient was given the above refraction in a trial frame, the patient stated it did not alleviate the ghosting, possibly 30 percent but not that much.

Manufacturer Narrative

Additional information: in the initial report the serial number was unknown.The serial number was provided therefore, the following information was updated.Section d4 model number: 0110-2261.Section d4 serial number: (b)(6).Section d4 unique identifier (udi) number: (b)(4).Section h3 device evaluated by manufacturer; yes.Section h4 device manufacture date: september 9, 2016.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: UNK_IDESIGN
• Type of Device: OPHTHALMIC REFRACTOMETER
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 12523415
• MDR Text Key: 273749028
• Report Number: 2020664-2021-07522
• Device Sequence Number: 1
• Product Code: HKO
• UDI-Public: (01)
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0110-2261
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR