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

Model Number MICL13.2

Device Problems Difficult To Position (1467); Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter stated the surgeon inserted a 13.2mm micl13.2 implantable collamer lens, -5.0 diopter, and noted the lens was too long for the patient's eye.The lens was removed within the same surgery with no patient injury.Another lens was not implanted.The surgeon felt the lens may have been mislabeled.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received - the reporter indicated the lens was inserted and removed from the left eye (os).The incision was enlarged to remove the lens and sutures were required to close the incision.The reporter indicated the icl would not position correctly and kept rotating out of position.During removal, the icl caught the iris which caused depigmentation and atrophy temporally.The patient experienced photosensitivity.

Manufacturer Narrative

Method: device history record review.Result: (no failure detected): based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Conclusion: (unable to confirm complaint): based on the complaint history, work order search, medical review, device history record review and product evaluation, 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5654689
• MDR Text Key: 45198843
• Report Number: 2023826-2016-00639
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103190
• UDI-Public: (01)00841542103190(17)171031
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2016

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
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/01/2016; 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR