MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNK_CARTRIDGE_PLATINUM_UNKNOWN; UNFOLDER PLATINUM 1 SERIES

Model Number 1MTEC30

Device Problems Crack (1135); Difficult to Advance (2920); Mechanical Jam (2983)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

If implanted, give date: not applicable as this is not an implantable device.  if explanted, give date: not applicable as this is not an implantable device.  the device is not available to be returned for analysis as the device was discarded.Therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.Device manufacture date: unknown as lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens (iol) advanced only halfway and did not advance any further when doctor began to advance the iol into patient's right eye.It was observed that the plunger had penetrated the cartridge under the iol.Additional information received confirmed that the plunger went under the iol in the cartridge after it had inserted the iol halfway into the patient's eye and the plunger had penetrated the bottom of the cartridge.The cartridge had a hole from the plunger on the bottom about 4mm from the tip.The lens was 50% in the eye and 50% out of the eye including the cartridge tip and would not advance any further.The incision was enlarged and a new lens of same model and diopter was implanted without any issues.There was no injury and no other medical/ surgical intervention was required.The procedure had a delay of 10 minutes and the patient had fully recovered.No further information is available.

• Brand Name: UNK_CARTRIDGE_PLATINUM_UNKNOWN
• Type of Device: UNFOLDER PLATINUM 1 SERIES
• 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: 11868043
• MDR Text Key: 264141808
• Report Number: 2648035-2021-07775
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 04/23/2021
• 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
• Patient Sequence Number: 1
• Patient Age: 58 YR