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

Model Number	MICL13.7
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pain (1994); Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Work order search: another similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter stated the surgeon implanted a 13.7mm micl13.7 implantable collamer lens, -10.0 diopter; in the patients right eye (od) on (b)(6) 2017.The reporter stated the lens was explanted on (b)(6) 2017 due to excessive vaulting; elevated intraocular pressure; narrowing of the angle and shallowing of the anterior chamber.The patient experienced blurry vision and pain.The lens was not exchanged for another lens.The reporter stated the cause of the event was unknown.
Additional Manufacturer Narrative
The lens was returned in a specimen cup.Visual inspection of the returned product found one haptic torn, with a piece torn off and missing.There was evidence of clear residue and debris on the lens.(b)(4).
Additional Manufacturer Narrative
The reporter indicated a shorter lens (13.2mm) was implanted on (b)(6) 2017 and the lens exchange resolved the problem.The lens vault was good and the intraocular pressure was normalized.The patient is doing good, with a visual acuity of 20/20.(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: 6574253
• Report Number: 2023826-2017-00834
• Device Sequence Number: 624105
• Product Code: MTA
• UDI-Device Identifier: 00841542103565
• UDI-Public: (01)00841542103565(17)181130
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2017

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: MICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: Not provided; 08/25/2017
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 06/07/2017; 08/25/2017
• 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