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

Model Number	MICL13.7
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer? no.Lens not returned.(b)(4).
Event or Problem Description
The reporter stated the surgeon implanted a 13.7mm micl13.7 implantable collamer lens, -9.0 diopter, in the patient's right eye (od) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to angle closure.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Implanted date - (b)(6) 2016.Method: device history record review.Result: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Visual inspection of the returned product found both haptics torn, with a piece missing.There was evidence of clear and dark color residue.Claim # (b)(4).
Event or Problem Description
Additional information received - the reporter indicated the lens in the right eye was unaffected, no malfunction or adverse event, and was only explanted due to difficulty with and removal of the icl lens in the left eye.The patient's post-op best-corrected visual acuity was 20/20.
Additional Manufacturer Narrative
Result code(s): (operational problem) : visual inspection of the returned product found both haptics torn, with a piece missing.There was evidence of clear and dark color residue.(no failure detected): based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the 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: ICL (IMPLANTABLE COLLAMER LENS)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 5593284
• Report Number: 2023826-2016-00509
• Device Sequence Number: 485780
• Product Code: MTA
• UDI-Device Identifier: 00841542103541
• UDI-Public: (01)00841542103541(17)161231
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2016

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: 12/31/2016
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/21/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/20/2016
• Supplement Report FDA Received Date: 07/01/2016; 09/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR