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

Model Number 1MTEC30

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Age, weight and ethnicity: unknown/ not provided. Catalog number : a complete catalog # is unknown, as the serial number was not provided. Lot number: unknown, information not provided. Expiration date: unknown, as the serial number was not provided. Udi number: a complete udi number is unknown, as the serial number was not provided. Implant date : not applicable as this is not an implantable device. Explant date : not applicable as this is not an implantable device. Initial reporter telephone number: (b)(6). Device manufacture date: unknown, as the serial number was not provided. Device evaluation: the product testing could not be performed as the product was not returned. The reported complaint cannot be confirmed. Manufacturing record evaluation: the manufacturing record review could not be performed because the serial number of the complaint product is unknown. Since the serial number is unknown, the complaint history review could not be performed. Conclusion: since the sample of the complaint product was not returned, and serial number is unknown, it is not possible to determine a malfunction and/or product quality deficiency. An attempt has been made to obtain missing information; however, to date, no response has been received. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

Event Description

It was reported that the intraocular lens (iol) could not advance through the cartridge. Doctor reloaded with a new lens using the same cartridge and when they advance the lens, a piece of plastic came out with into the eye. Attempt made for information on the iol but not available. No further information available.

• 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
• Manufacturer Contact: somyata nagpal ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 12105553
• MDR Text Key: 265606829
• Report Number: 2648035-2021-08080
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial