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

Model Number	MICL12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Headache (1880); Intraocular Pressure Increased (1937); Nausea (1970); Pain (1994); Pupillary Block (2026); Blurred Vision (2137); Vomiting (2144); No Code Available (3191)
Date of Event	12/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter stated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -11.0 diopter, in the patient's eye on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to extreme vaulting.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information was received: the reporter indicated the patient called post-surgery with extreme pain, headache, nausea and vomiting.The patients pressure was 50.The wound was burped but would not go down below 37.A secondary yag pi was performed but with no pressure relief.There was narrowing of the angle and mechanical angle closure.The lens was explanted on (b)(6) 2016 and a shorter lens was implanted on (b)(6) 2016.The patients current va is 20/20 and is doing well.The reporter stated the event was product-related.Device evaluation: visual inspection of the returned product found one haptic torn.The lens was returned in liquid and there was clear residue on the lens.Work order search: no similar complaints were reported for units within the same lot.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6324404
• Report Number: 2023826-2017-00233
• Device Sequence Number: 1159717
• Product Code: MTA
• UDI-Device Identifier: 00841542103046
• UDI-Public: (01)00841542103046(17)180531
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 01/24/2017

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: 05/31/2018
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 03/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Weight: 63