MAUDE Adverse Event Report: BOSTON FOUNDATION FOR SIGHT BOSTONSIGHT PROSE

Model Number	N/A
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Corneal Abrasion (1789)
Date of Event	01/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Device broke while in patients eye.
Additional Manufacturer Narrative
·the device in question was manufactured on 8/8/22 - 15 months old.·the design profile for the lens was reviewed.The thickness was adequate and per specification, and the designs were stable ·the fit connect work order and process control log were reviewed - the thickness was adequate and per specification, and the design was stable.The device was manufactured correctly and within all specified tolerances ·no other complaints have been logged for this specific b&l material lot number ·a review of the nonconforming materials reports shows no ncr's logged for this specific material lot number ·the b&l certificate of analysis and incoming inspection reports for the lot were reviewed - no issues with the material.

• Brand Name: BOSTONSIGHT PROSE
• Common Device Name: BOSTONSIGHT PROSE
• Manufacturer (Section D): BOSTON FOUNDATION FOR SIGHT; 464 hillside ave; suite 205; needham MA 02494
• Manufacturer (Section G): BOSTON FOUNDATION FOR SIGHT; 464 hillside ave; suite 205; needham MA 02494
• Manufacturer Contact: paul piselli ; 464 hillside ave; suite 205; needham, MA 02494 ; 7816759943
• MDR Report Key: 18465698
• Report Number: 3006204913-2024-00001
• Device Sequence Number: 7192087
• Product Code: HQD
• UDI-Device Identifier: 00785811435677
• UDI-Public: (01)00785811435677(10)21363007
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K183175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: 21363007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Female