MAUDE Adverse Event Report: ALTAIR/MARCHON ITALIA SRL OTIS AND PIPER OP4001 EYEGLASSES; FRAME, SPECTACLE

Model Number OP4001

Device Problem Break (1069)

Patient Problems Eye Injury (1845); Laceration(s) (1946)

Event Date 12/19/2021

Event Type  Injury  

Event Description

My son has a pair of otis and piper glasses frames, which have broken twice (two separate frames, after being replaced) in the same manner.Both times, they broke exposing a metal screw that was pointed towards his eye, and cut his eye.If he had fallen or been bumped slightly over, it would have punctured his eyeball.The first time, the frames broke after another child at school bumped him.This time, the replacement frames broke after he fell down.Both times, the same screw was exposed and punctured his eye.Fda safety report id # (b)(4).

Event Description

Additional information received from a reporter on 02/18/2022 for a report number mw5106267.

Event Description

Additional information received from a reporter on 02/18/2022 for a report number mw5106267.

• Brand Name: OTIS AND PIPER OP4001 EYEGLASSES
• Type of Device: FRAME, SPECTACLE
• Manufacturer (Section D): ALTAIR/MARCHON ITALIA SRL
• MDR Report Key: 13087451
• MDR Text Key: 282890729
• Report Number: MW5106267
• Device Sequence Number: 1
• Product Code: HQZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 12/21/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: OP4001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2022
• Patient Sequence Number: 1
• Treatment: EYEGLASSES; VYVANSE
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Sex: Male
• Patient Weight: 19 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White