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

Model Number	MICL12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth - unk.(b)(4).Claim # 429083.
Event or Problem Description
The reporter stated the surgeon inserted a 12.6mm micl12.6 implantable collamer lens, -6.0 diopter, in the patient's left eye (os) on (b)(6) 2016.The lens was noted to be too big and was removed during the same surgery with no patient injury or complications.The lens was not exchanged for another lens.The reporter stated the cause of the event was unknown.
Additional Manufacturer Narrative
Device evaluated by manufacturer?: visual inspection of the returned product found no visible damage to the lens.The lens was returned dry with residue.Method: work order search.Result: a work order search was performed and no similar complaints were found.Conclusion: based on the complaint history, work order search, medical review and product evaluation, a specific root cause of the event could not be determined.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6089900
• Report Number: 2023826-2016-01608
• Device Sequence Number: 294932
• Product Code: MTA
• UDI-Device Identifier: 00841542102940
• UDI-Public: (01)00841542102940(17)171231
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2016

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: 12/31/2017
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2016
• Supplement Report FDA Received Date: 02/24/2017
• 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; INJECTOR MODEL AND LOT NUMBER UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR