MAUDE Adverse Event Report: LENSTEC BARBADOS INC. SOFTEC I; INTRAOCULAR LENS

Lot Number	174364
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned in the vial, the cap was on the vial but the bung was absent.The outer pouch was also absent but the remainder of the packaging components were present.Inspection was performed at 10x magnification under a stereoscopic microscope.The lens was intact and one haptic carried a scratch.No other defects were noted.The dimension check conducted showed that the lens was within specification.A full audit of all batch documentation relating to the production of the devices was performed.The audit concluded that all procedures in manufacturing and packaging of the devices had been conducted correctly.Batch reconciliation was 100.0%.Based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the devices were conducted correctly.The lens was intact and within specification.There was no evidence to suggest that any aspect of the lens was responsible for the surgical complication reported.[(b)(4) pdf].
Event or Problem Description
Lenstec received and email stating "dr.Had trouble centering the lens so she took it out".The implant/explant date was (b)(6) 2018.The incision was enlarged to remove the lens and there was no patient injury.

• Brand Name: SOFTEC I
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, BB170 92; BB BB17092
• MDR Report Key: 7660507
• Report Number: 9613160-2018-00029
• Device Sequence Number: 13739703
• Product Code: HQL
• UDI-Device Identifier: 00844369029605
• UDI-Public: 00844369029605
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: 01/10/2023
• Device Lot Number: 174364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1