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 Code	No Code Available (3191)
Date of Event	03/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned product found a scratch on one haptic.The lens was returned in liquid.(b)(4).
Event or Problem Description
The reporter stated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -8.5 diopter, in the patients right eye (od) on (b)(6) 2016.The patient was removed to recovery.The patient was checked a short time later and the lens was noted to have a low vault.The patient was returned to surgery, the lens was explanted the same day, and a longer lens was implanted.The reporter stated there was no patient injury and the cause was unknown.
Additional Manufacturer Narrative
Additional information was received - patients post-op uncorrected visual acuity was 20/15, with good vision.(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: 6415477
• Report Number: 2023826-2017-00419
• Device Sequence Number: 10775230
• Product Code: MTA
• UDI-Device Identifier: 00841542103268
• UDI-Public: (01)00841542103268(17)171130
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2017

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: 11/30/2017
• Device Model Number: MICL13.2
• 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: 02/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 03/24/2017
• 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 SFC-45 FP - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL MSI-PF - LOT NUMBER UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR