MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER PLATINUM 1 SERIES; LENS, GUIDE, INTRAOCULAR

Model Number 1MTEC30

Device Problem Crack (1135)

Patient Problems Corneal Edema (1791); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

If implanted, give date: not applicable, the cartridge is not an implantable device.If explanted, give date: not applicable, the cartridge is not an implantable device.Telephone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that in one of the procedures it was necessary to increase the incision of 2.2 mm because surgeon alleged the cartridge gauge is not compatible to the incision size.In this case the intraocular lens (iol) was implanted in the patients endothelium with manipulations to insert the lens into the bag.It was the size of the incision to accommodate the cartridge that caused discomfort during the implant.Lens was fully inserted into the eye.Additional information states that tip of the cartridge is not correspondent to the incision of 2.2 mm, causing the difficulty during the insertion of the iol.There was also corneal edema near to the incision.No other information provided.

Manufacturer Narrative

Additional information: section h6: health effect - impact code: 3191 device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record evaluation: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: UNFOLDER PLATINUM 1 SERIES
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11593935
• MDR Text Key: 244195577
• Report Number: 2648035-2021-07480
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)210812(10)CH11853
• Combination Product (y/n): N
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2021
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CH11853
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZCT150 LENS SN: (B)(6)