MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV SCLERAL BUCKLING PRODUCTS: STYLE 41, 3.5MM SILICONE STRIP

Catalog Number	92-09
Health Effect - Clinical Code	Reaction (2414)
Date of Event	02/04/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot review: there is nothing relative to the complaint.The material used is medical grade implantable silicone.After testing the root cause is inconclusive for an allergice reaction.This complaint is considered an isolated incident.Sample analysis: no sample was received.Conclusion: the complaint is not confirmed.(b)(4).All available information has been disclosed.This complaint has now been closed.Please note that 2 mdrs submitted for the 2 parts that were used together in the implant 1222074-2018-00052 and 1222074-2018-00053.
Event or Problem Description
It was reported a patient had a scleral buckle implanted in right eye one year ago.The patient then had an allergice reaction on the skin surrounding her eye and was seen by a dermatologist.The patient was evaluated for a possible allergic reaction related to silicone.It was reported the md wants to perform an allergy test.

• Brand Name: SCLERAL BUCKLING PRODUCTS: STYLE 41, 3.5MM SILICONE STRIP
• Common Device Name: SCLERAL BUCKLING PRODUCTS: STYLE 41, 3.5MM SILICONE STRIP
• Manufacturer (Section D): D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands ; NL
• MDR Report Key: 7346904
• Report Number: 1222074-2018-00052
• Device Sequence Number: 1740448
• Product Code: HQX
• UDI-Device Identifier: 08717872014319
• UDI-Public: 08717872014319
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2015

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?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 92-09
• Device Lot Number: 160708
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2015
• Initial Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention