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

Model Number	SOFTEC HD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	08/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the lens was received by the manufacturer a visual inspection was performed.The lens was received in the vial with all the packaging components except the outer pouch.The inspection was performed at x15 magnification using a stereoscopic microscope.The lens was in one piece and both haptics were intact.The optic carried two cuts - one from the edge of the haptic to half ways through the optic.The second cut was next to the first cut and extended about a quarter ways through the optic.Both cuts went straight through the optic.There was also an indentation present on the optic; this appeared to have been made by tweezers or some other instrument which was used to grasp the lens.No other damage was noted, the lens was clean and no foreign particles were seen.The cartridge used was not returned for investigation but the lens model and diopter are compatible with the cartridge.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 batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Based on the lens inspection, the damage on the optic appeared to be deliberate cuts with a sharp instrument, probably to facilitate the removal of the lens from the eye.The indentation appeared to have been caused by tweezers or some other instrument used to grasp the lens in the damaged area.There was no evidence to suggest that any aspect of the lens was responsible for the surgical complication reported.Additionally, lenstec believes that the lens, its design and the manufacturing process are not at fault due to the extensive testing that we have performed on this model.Lenstec has also conducted extensive testing on the lens model and the instruments used and our results indicate that these devices are compatible.
Event or Problem Description
Reported "torn capsule, lens put in sulcus.Power and lens changed per physician.".

• Brand Name: SOFTEC HD
• Common Device Name: INTRAOCULAR LENS- SOFTEC HD
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church 17092 ; BB
• MDR Report Key: 6846329
• Report Number: 9613160-2017-00005
• Device Sequence Number: 10778175
• Product Code: HQL
• UDI-Device Identifier: 00844369027427
• UDI-Public: 00844369027427
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Medical Assistant
• Type of Report: Initial
• Report Date (Section B): 09/06/2017

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: 12/13/2018
• Device Model Number: SOFTEC HD
• Device Lot Number: 134631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1