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

Model Number MICL13.2

Device Problems Difficult to Advance (2920); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

Method: (process evaluation): work order search results: (evaluation result): a lens work order search was performed and another similar complaint was found within the work order.Conclusion: (unable to confirm complaint): based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).

Event Description

The reporter stated the surgeon attempted to insert a 13.2mm micl13.2 implantable collamer lens, -14.0 diopter but the lens became stuck in the cartridge and tore.The reporter stated it was unknown if there was any patient contact.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Method: device history record review, medical review.Results: a review of the device history record was performed and nothing was found in the manufacturing, inspection and packaging process records to suggest a contributory factor to the complaint.Medical review - reportedly, micl (13.2 mm) was stuck in the injector and was subsequently torn off during insertion requiring intraoperative exchange.No reported incision enlargement or any other tissue damage.According to report , by an office manager, dated on (b)(6) 2015 there was no confirmation if the lens had a patient contact.No reported postoperative sequelae.Visual inspection of the returned product found two lenses stuck together in one vial.The lenses were returned dry and could not be evaluated due to the returned condition.Conclusion: based on the complaint history, work order search, device history record review, medical review and the returned product, a specific root cause of the event could not be determined.(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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5323172
• MDR Text Key: 34270439
• Report Number: 2023826-2015-01722
• Device Sequence Number: 1
• Product Code: MTA
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2015
• 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 AND LOT NUMBER UNK
• Patient Age: 42 YR