MAUDE Adverse Event Report: PRIMAPHARM, INC. SILIKON 1000 OIL; FLUID, INTRAOCULAR

Catalog Number 8065601185

Device Problem Insufficient Information (3190)

Patient Problem Visual Disturbances (2140)

Event Type  Injury  

Event Description

A doctor reports that a patient is experiencing reduced central vision after ophthalmic oil was used during their procedure.Additional information has been requested.

Manufacturer Narrative

No sample or lot number information was received by manufacturing for evaluation.Intra-lot complaint history review was performed due to no lot code or sample received.There have been no similar issues reported in the past year.No further evaluation or root cause analysis can be conducted at this time.No root cause could be determined.Additional information has been requested, but none has been received.(b)(4).

• Brand Name: SILIKON 1000 OIL
• Type of Device: FLUID, INTRAOCULAR
• Manufacturer (Section D): PRIMAPHARM, INC.; 3443 tripp court; san diego CA 92121
• Manufacturer (Section G): PRIMAPHARM, INC.; 3443 tripp court; san diego CA 92121
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 4916179
• MDR Text Key: 6049523
• Report Number: 1610287-2015-00520
• Device Sequence Number: 1
• Product Code: LWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065601185
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2015
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other