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

Model Number	GCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Telephone number: (b)(6).Device evaluation: product evaluation could not be performed since the product was not returned for evaluation.Per information provided material is not available.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record evaluation: the manufacturing records for the intraocular lens 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.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the customer sent in a fax indicating the lens was unsterile / defective.No further details were given.Product investigation was completed without sample return.No other information was provided.
Additional Manufacturer Narrative
H2- additional information: as per information received, it was confirmed by the customer that there was a defect in the middle of the lens and the lens was removed and replaced by a new one.No patient injury.Also, event date confirmed to be on (b)(6) 2021.No further information provided.The following fields were updated accordingly.Section b2: event date: (b)(6) 2021.Section h6: health effect - impact code.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SMARTLOAD
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11833689
• Report Number: 2648035-2021-07817
• Device Sequence Number: 11794639
• Product Code: HQL
• UDI-Device Identifier: 05050474620674
• UDI-Public: (01)05050474620674(17)231013
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2023
• Device Model Number: GCB00
• Device Catalogue Number: GCB0000235
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1