MAUDE Adverse Event Report: STAAR SURGICAL COMPANY COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE IOL; INTRAOCULAR LENS

Model Number	CQ2015A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a cq2015a, +18.0 diopter, intraocular lens in the patient's left eye (os) on (b)(6) 2018.During insertion, the surgeon felt the injector got harder to push when injecting the lens.The trailing haptic and a bit of the optic got caught by the plunger.The lens had to be cut out.A back-up similar lens was intraoperatively exchanged with it and it was successfully implanted.There was no patient injury.It was also reported that the anikavisc viscoelastic was used and the lens was in the injector for less that a minute.
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned in liquid in a lens case/vial.Visual inspection found the optic torn, the lens torn into three pieces, and a piece of the optic missing.Claim # (b)(4).
Additional Manufacturer Narrative
Additional data: device history record (dhr) review: 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.Corrected data: device evaluation: the msi-pm injector was returned loose in a lens box.Visual observation found the msi-pm injector with no visible damage and clear residue on cartridge.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data type of report- follow-up #2 for mdr # 2023826-2018-00464 was not submitted.It was inadvertently skipped and follow-up#3 was submitted instead.Claim# (b)(4).

• Brand Name: COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7378743
• Report Number: 2023826-2018-00464
• Device Sequence Number: 16514446
• Product Code: HQL
• UDI-Device Identifier: 00841542101943
• UDI-Public: 00841542101943
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: CQ2015A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 03/16/2018; 03/18/2019; 03/18/2019
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 03/28/2018; 04/02/2019; 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR