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

Model Number 1MTEC30

Device Problems Use of Device Problem (1670); Inaccurate Delivery (2339)

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

Event Date 10/20/2021

Event Type  malfunction  

Event Description

It was reported that the intraocular lens (iol) had loading issue that it advanced too far out of cartridge when trying to insert the lens into patient's left eye. The lens was partially delivered into the eye. The patient has recovered. No further information was provided.

Manufacturer Narrative

Lot number: unknown, information not provided. Expiration date: unknown, as the lot number was not provided. Udi number: a partial udi number is known, as the lot number was not provided. Implant date: if implanted, give date: not applicable as this is not an implantable device.   explant date: if explanted, give date: not applicable as this is not an implantable device.   device evaluated by mfr: the device was not returned for analysis. Therefore, a failure analysis of the complaint device cannot be completed. A review of the device history record, complaint trending, and risk documentation for this device will be performed. Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed. Device manufacture date: device manufacture date: unknown as lot number was not provided. All pertinent information available to johnson & 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
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13436393
• MDR Text Key: 294152944
• Report Number: 3012236936-2022-00294
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• 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
• Date Manufacturer Received: 01/03/2022
• 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

Patient Treatment Data

Date Received: 02/03/2022 Patient Sequence Number: 1

Treatment

ZCB00 LENS SN: (B)(4)