MAUDE Adverse Event Report: STAAR SURGICAL COMPANY ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS

Model Number MICL12.6

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The reporter stated the surgeon noted a substance/residue on a 12.6mm micl12.6 implantable collamer lens, -10.5 diopter, and the lens was not used.There was no patient contact.The backup lens was implanted.

Manufacturer Narrative

Device evaluated by manufacturer?: visual inspection of the returned product found no visible damage to the lens.The lens was returned in liquid.The lens was re-examined under 20x magnification and no defects were detected on the lens.If the substance is now in solution, we cannot isolate it because it is not clear what the particulate is or how it looks like.Method: work order search.Result: a lens work order search was performed and no similar complaints were found.Conclusion: based on the complaint history, work order search and product evaluation, a specific root cause of the event could not be determined.Claim # (b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6191976
• MDR Text Key: 62911404
• Report Number: 2023826-2016-01783
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103039
• UDI-Public: (01)00841542103039(17)171130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2017
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL MSI-PF - LOT NUMBER UNK
• Patient Age: 43 YR