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

Model Number MICL12.6

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

Patient Problems Headache (1880); Pain (1994); Blurred Vision (2137); Vomiting (2144); No Code Available (3191)

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Results: visual inspection of the returned product found pieces of one haptic torn off and missing.The lens was returned in a small clear container.(b)(4).

Event Description

The reporter stated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -12.0 diopter, in the patient's left eye (os) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to the lens being too large and hypotony (low iop).The patient experienced blurred visual acuity, eye pain, headache, and vomiting.The reporter indicated that the cause of the event was unknown.The patient's post-op best-corrected visual acuity (bcva) was 20/25.

• 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: 5788401
• MDR Text Key: 49368789
• Report Number: 2023826-2016-00898
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103060
• UDI-Public: (01)00841542103060(17)171231
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2016

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?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 71