MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SMARTLOAD; INTRAOCULAR LENS

Model Number GIB00

Device Problem Difficult to Insert (1316)

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

Event Date 01/30/2022

Event Type  Injury  

Manufacturer Narrative

Age, weight, ethnicity: per regulation (eu) 2016/679 (general data protection regulation), patient identifiers should not be collected or recorded or shared with any third parties; therefore the information is not provided.If explanted, give date: n/a (not applicable).The lens remains implanted.Initial reporter first/given name: full name not provided.(b)(6).The intraocular lens (iol) is not returning for evaluation as it remains implanted; 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the iol (intraocular lens) was delivered upside down in the patient's operative eye.The surgeon had to twist the lens and turn it in the eye.The lens remains fully implanted.Through follow-up, it was confirmed that the patient is doing well and that there were no complications.The surgeon used an extra instrument to reposition the lens inside the eye.Product is not returning for evaluation as it remains implanted.No further information were provided.

• Brand Name: SMARTLOAD
• Type of Device: INTRAOCULAR LENS
• 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: 13596344
• MDR Text Key: 290057228
• Report Number: 3012236936-2022-00503
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474654945
• UDI-Public: (01)05050474654945(17)240623
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: GIB00
• Device Catalogue Number: GIB00I0265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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 Outcome(s): Required Intervention