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

Model Number MICL12.6

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Headache (1880); Intraocular Pressure Increased (1937); Nausea (1970); Pain (1994); Pupillary Block (2026); Blurred Vision (2137); Vomiting (2144); No Code Available (3191)

Event Date 12/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event 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.

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)
• Type of Device: PHAKIC 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: 6324404
• MDR Text Key: 67206590
• Report Number: 2023826-2017-00233
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103046
• UDI-Public: (01)00841542103046(17)180531
• 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,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2016
• 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
• Treatment: CARTRIDGE MODEL AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 63