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

Lot Number	172794
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	01/23/2018
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 x10 magnification using a stereoscopic microscope.The lens was in two pieces, separated by a cut with a serrated edged instrument and both haptics was intact.No other damage was noted, traces of what appeared to be saline particles was noted on the surface of the lens.The cartridge used was not returned for investigation but the lens model and diopter are compatible with the cartridge.Additionally, the injector was not returned, but is compatible.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.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
Lenstec received an email notification indicating "softec 1 was injected into the eye.The patient had a posterior capsular rupture and had to cut lens out and then put in a 3-piece lens".

• 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: 7278619
• Report Number: 9613160-2018-00013
• Device Sequence Number: 2301402
• Product Code: HQL
• UDI-Device Identifier: 00844369029421
• UDI-Public: 00844369029421
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/15/2018

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: 09/10/2022
• Device Lot Number: 172794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1