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

Model Number MICL12.6

Device Problems Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)

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

Event Date 04/27/2015

Event Type  malfunction  

Event Description

The reporter stated the surgeon inserted a 12.6mm micl12.6 implantable collamer lens but the lens appeared twisted and was not positioned properly in the eye.The lens was removed within the same surgery, with no patient injury.The backup lens was implanted with no problem.

Manufacturer Narrative

(b)(4).Results - a lens work order search was performed and no similar complaints were found within the work order.Visual inspection of the returned product found no visible damage to the lens.The lens was returned in liquid.The injector, cartridge and foam tip plunger were not returned for evaluation.Conclusions - based on the complaint history, work order search and the evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).

Manufacturer Narrative

This complaint file states that the lens appeared twisted, and was not properly positioned in the eye.There is no information to determine if there was any malfunction of the insertion system, but a work-order search showed no similar complaints.There is no information to determine if misplacement of the lens was due to improper lens loading or surgeon handling.Based on the complaint history, work order search, medical review and the evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).

Manufacturer Narrative

Method - (process evaluation): device history record review.Results - (evaluation result): 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.Conclusion - (unable to confirm complaint): based on the complaint history, work order search, medical review, product evaluation and the device history record review, 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: 4820212
• MDR Text Key: 19642150
• Report Number: 2023826-2015-00641
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: MICL12.6
• Other Device ID Number: DIOPTER -8.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2014
• 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
• Patient Age: 31 YR