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

Model Number	MICL12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Headache (1880); Pain (1994); Blurred Vision (2137); Vomiting (2144); No Code Available (3191)
Date of Event	06/07/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 5788401
• Report Number: 2023826-2016-00898
• Device Sequence Number: 16485467
• Product Code: MTA
• UDI-Device Identifier: 00841542103060
• UDI-Public: (01)00841542103060(17)171231
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2016
• Initial Report FDA Received Date: 07/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 71