MAUDE Adverse Event Report: LENSTEC (BARBADOS) INC. SOFTEC HD PLI; INTRAOCULAR LENS, PRODUCT CODE: HQL

Model Number	SOFTEC HD PLI
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information was requested from the facility and no information was provided.Lenstec cannot corroborate the claim of "fragments of the plunger were left in the eye".Requested items, i.E.Photos, patient condition, patient history were not provided.The lens remains implanted.Lenstec can confirm that all procedures in the manufacturing and packaging of the pli device were conducted correctly.The visual inspection carried out revealed no defects on the folding cams, closing cam or the pli tip.However, the plunger was slightly bent and during manipulation, it was hitting the pli body resulting in the two specks seen.All dimensions for these components were within specification.The pli body also carried no defects.Lenstec can confirm that all pli components are inspected during assembly of the pli to ensure that they meet our quality standards.Additionally, the review of the receiving documentation for all the pli components showed no defects when the components were first received.Lenstec has also conducted extensive testing on these pli devices, both during design and in the manufacturing process.As such, lenstec recommends that the instructions for use which are enclosed with each pli be carefully followed to ensure successful implantation of the lens.
Event or Problem Description
Lenstec received a customer complaint stating "fragments of the plunger were left in the eye, had to remove with visco, some left in cornea but looked ok 2 days post op".

• Brand Name: SOFTEC HD PLI
• Common Device Name: INTRAOCULAR LENS, PRODUCT CODE: HQL
• Manufacturer (Section D): LENSTEC (BARBADOS) INC.; airport commercial centre; pilgrim road; christ church, BB170 92; BB BB17092
• MDR Report Key: 5811973
• Report Number: 9613160-2016-00004
• Device Sequence Number: 687081
• Product Code: HQL
• UDI-Device Identifier: 00844369002851
• UDI-Public: 00844369002851
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P090022/S012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2016

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: 08/06/2016
• Device Model Number: SOFTEC HD PLI
• Device Lot Number: 133237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2016
• Initial Report FDA Received Date: 07/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1