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

Model Number MICL12.1

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method (process evaluation): work order search.Results (evaluation result): a lens work order search was performed and no similar complaints were 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).Lens not returned.

Event Description

The reporter stated the surgeon inserted a 12.1mm micl12.1 implantable collamer lens, -5.5 diopter but the lens would not unfold in the patient's eye, the lens was on its side and looked like a "taco".The lens was removed with no patient injury, no enlarged incision or sutures and the backup lens was implanted.

Manufacturer Narrative

Per medical review - this complaint file states that the lens did not unfold.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 unfolding was due to improper lens loading, or surgeon handling either.Visual inspection of the returned product found a piece of one haptic torn off and missing.The lens was returned dry and there was evidence of clear surgical residue.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).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY AG; hauptstrasse 104; ch-2560, nidau ; SZ
• Manufacturer (Section G): STAAR SURGICAL COMPANY AG; hauptstrasse 104; ch-2560, nidau ; SZ
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5119132
• MDR Text Key: 27305560
• Report Number: 2023826-2015-01259
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/03/2015

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: 10/31/2015
• Device Model Number: MICL12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2013
• 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