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

Model Number	MICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Corneal Edema (1791); Intraocular Pressure Increased (1937); Pupillary Block (2026); No Code Available (3191)
Date of Event	03/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: returned product evaluation found the lens returned dry in gauze with clear surgical residue on product.Visual inspection found the lens haptic torn and missing piece of the haptic.(b)(4).Work order search: no similar claims were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated that a micl13.2, -6.5 diopter, implantable collamer lens was implanted in the patient's left eye on (b)(6) 2017.The lens was explanted on (b)(6) 2017 due to pupillary block causing elevated iop.The reporter indicated the patient had excessive vault, narrowing of the angle, angle closure and shallowing of the acd.The patient's reported condition at the time of the last visit on (b)(6) 2017 was 20/70 bcva, normal iop and corneal edema.
Additional Manufacturer Narrative
At the time of surgery patient was (b)(6) and per dfu indications visian implantable collamer lenses (vicl) are indicated for use in phakic eye treatment in adults (b)(6) of age.There is no significant safety and effectiveness data to support implantation in such patients.(b)(4).
Additional Manufacturer Narrative
Based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.(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: 6501830
• Report Number: 2023826-2017-00562
• Device Sequence Number: 13753460
• Product Code: MTA
• UDI-Device Identifier: 00841542103220
• UDI-Public: (01)00841542103220(17)181130
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2017

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: 11/30/2018
• Device Model Number: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: Not provided; 07/17/2017
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 06/12/2017; 07/24/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Weight: 54